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At our institution, we routinely use pulmonary artery catheters (PAC) for critically ill and complex cardiothoracic surgical cases. Recently, upon removal of the PAC in two separate cases, failure of the Integral Hemostasis Valve was noted with brisk bleeding out of the introducer port. In both cases, valve failure led to patient harm and intervention was necessary.
Dear Rapid Response:
At our institution, we routinely use pulmonary arterial catheters (PAC) to assist in the management of critically ill and complex cardiothoracic surgery patients. On two occasions over the course of one month, removal of these PACs resulted in apparent mechanical failure of the one-way valve of the introducer sheath. Both of these cases resulted in patient harm with the need for intervention. We report both cases here.
Case #1: This event involved a 69 year old man who underwent a combined coronary artery bypass grafting and Bentall procedure and was admitted to the ICU postoperatively. After a complicated post-operative course and multiple returns to the operating room, he stabilized enough to remove his PAC. With the balloon deflated, the PAC was removed. Immediately upon removal, profuse bleeding was noted from the white introducer port of the ARROWgard Blue Two-Lumen 9 French 10 cm central venous catheter with Integral Hemostasis Valve (AK-11142-SPCS). We attempted to salvage the line by separately placing an 8 French light blue obturator cap over the hub. When this failed, we then attempted to place an Arrow Hands-Off Two-Lumen 7 French 30 cm central venous catheter (HO-14702) through the defective one-way valve. This also failed, with continued bleeding through the port. Therefore, we manually occluded the hub and removed the entire introducer sheath. Upon inspection, we noted that the white cap and rubber one-way valve were intact with no apparent evidence of damage or dislodgement. This patient required subsequent central line replacement for continued care.
Figure 1. This photo from case #2 depicts the Integral Hemostasis Valve inadvertently removed with the PAC.
Case #2: This event involved a 63 year old woman anticoagulated on veno-arterial extracorporeal membrane oxygenation (ECMO) with synthetic liver dysfunction after a complicated redo aortic and mitral valve replacement procedure. The patient’s clinical status was permissive to PAC removal. However, when we removed the catheter, there was profuse bleeding through the introducer port of the same two-lumen ARROWgard introducer sheath as in Case #1 (AK-11142-SPCS). In this case, the Integral Hemostasis Valve as well as the white plastic cap that normally occludes the proximal end of the introducer were both noted to have been completely dislodged by the PAC removal, allowing the free flow of blood out of the introducer. Due to our previous experience, we immediately removed the introducer. This patient required not only central line replacement but also blood product transfusions due to blood lost via the introducer port.
Figure 2. This is a photo from case #2 of the central venous catheter with no valve-apparatus visible, with the lumen open to air.
Thankfully, neither patient suffered long-term injury from this equipment malfunction. However, we believe this is a very important patient safety issue. This valve malfunction can lead to significant bleeding, infection, venous air embolism, and loss of large bore central access for vasoactive drugs and resuscitation endeavors. Arrow International, Inc., a subsidiary of Teleflex, Inc., was contacted regarding the incident.
Samuel Hong, MD, Clinical Assistant Professor in the UCI Department of Anesthesiology and Perioperative Medicine: Division of Critical Care Medicine.
Michael Lin, MD, Clinical Assistant Professor in the UCLA Department of Anesthesiology and Perioperative Medicine: Division of Critical Care Medicine.
The authors have no conflicts of interest.
Reply:
Response from Teleflex:
Dear Editor: On behalf of Teleflex, I would like to extend my thanks for giving us the opportunity to provide a response/feedback regarding the extraordinarily rare issue described in this article. We take patient safety and the quality of our medical devices very seriously. Unfortunately, in this case, the devices were not returned to Teleflex, so the proper testing and evaluation of the devices could not take place to determine the root cause. Therefore, in the interests of patient safety, I would strongly encourage clinicians, regardless of the device or manufacturer, to not only share the experience with their colleagues through an effective forum such as this publication, but also – more importantly – to return (if at all possible) any medical devices in which there are unanticipated issues encountered back to the manufacture as soon as possible, so that a thorough root cause investigation can take place to determine if there is indeed a product quality issue.
Chris Davlantes, MD, FACEP
Medical Director
Vascular & Emergency Medicine
Global Clinical & Medical Affairs
Teleflex
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