BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER GUIDE WIRE

    MDR report key: 8250605 · Received January 15, 2019

    Report

    Report Number
    1220648-2019-00005
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Date of Event
    December 21, 2018
    Report Date
    December 21, 2018
    Manufacturer
    ABIOMED EUROPE GMBH
    Product Code
    OFB
    PMA / PMN Number
    P1400003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 1

    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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41761 CATHETER GUIDE WIRE GUIDEWIRE, IMPELLA 0.018" OFB ABIOMED EUROPE GMBH GUIDE WIRE 0.018" PTFE COATED 11057806

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R