Penumbra—JET 7 Reperfusion Catheters with Xtra Flex Technology: Distal Tip May Expand or Rupture
August 19, 2020 | Risk Management News
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In a July 27, 2020, Notification to Healthcare Providers letter submitted by ECRI member hospitals, Penumbra states that it has received reports of the above catheters exhibiting distal tip expansion or rupture when used during injection of contrast media. Distal tip expansion or rupture may cause vessel damage and subsequent patient injury or death. The problem is caused by the distal tip weakening from manipulation against resistance or use with other manufacturers' revascularization devices. Performing contrast injections through the JET 7 Xtra Flex is not consistent with the intended use of the product or the instructions for use (IFU), which instruct the user to perform contrast injections through the guide catheter. The use of JET 7 Xtra Flex with other manufacturers' revascularization devices is not an authorized use. JET 7 Xtra Flex has not been tested for compatibility with other manufacturers' revascularization devices. Through bench testing, based on the device design, the JET 7 Xtra Flex may not be able to withstand the same burst pressures in comparison to the JET 7 reperfusion catheter or the ACE 68 reperfusion catheter. The manufacturer has not confirmed the...