CATHETER GUIDE WIRE

Additional Manufacturer Narrative

SINCE THE ORIGINAL MEDWATCH WAS FILED, THE INVESTIGATION HAS COMPLETED. THE PRODUCT AND DATA LOGS WERE RETURNED FOR ANALYSIS. A CLINICAL REPORT AND CASE DISCUSSION WAS SHARED WITH THE INVESTIGATORS. THE INVESTIGATION DETERMINED THAT THE IMPELLA PUMP'S REPOSITIONING UNIT WAS UNINTENTIONALLY INTRODUCED INTO THE 14FR INTRODUCER, DURING THE PUMP INSERTION AT THE FEMORAL ARTERY. THE TEAM THEN FOUND A NEED TO USE EXCESSIVE FORCE TO REMOVE THE GUIDEWIRE FROM THE PUMP, WHICH WAS POSITIONED WITHIN THE INTRODUCER. THE FORCE APPLIED CAUSED THE GUIDEWIRE TO FRACTURE. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE OF GUIDEWIRE FRACTURE.

Additional Manufacturer Narrative

TO DATE THE PRODUCT HAS NOT YET BEEN RETURNED FROM COMPLAINANT IN (B)(6). UPON COMPLETED INVESTIGATION THE SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

DURING A CORONARY INTERVENTION THE TEAM IN (B)(6) CHOSE TO HAVE AN IMPELLA CP PLACED FOR SUPPORT DURING THE HIGH RISK INTERVENTION. THE CP WAS PLACED AND UPON ATTEMPTED REMOVAL OF THE .018 GUIDEWIRE, THE WIRE BECOME DAMAGED AND FRACTURED. THE WIRE WAS PULLED WITH FORCE. THERE WAS A PORTION OF THE WIRE RETAINED WITHIN THE PATIENT'S VASCULAR ANATOMY UPON TRANSFER TO THE ICU FOR CONTINUED MONITORING. LATER THE FAMILY CHOSE TO WITHDRAW CARE AND THE IMPELLA PUMP WAS REMOVED.