BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER GUIDE WIRE

    MDR report key: 8425535 · Received March 15, 2019

    Report

    Report Number
    1220648-2019-00041
    Event Type
    Malfunction
    Date Received
    March 15, 2019
    Date of Event
    February 22, 2019
    Report Date
    February 22, 2019
    Manufacturer
    ABIOMED
    Product Code
    OFB
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT DID RETURN THE PROXIMAL END OF THE 0.018" GUIDEWIRE, IMPELLA PUMP, THE ACCESSORY CABLE, 14FR INTRODUCER SHEATH, AND PURGE CASSETTE FOR ANALYSIS. THE FRACTURED PORTION OF THE GUIDEWIRE TIP WAS NOT RETURNED FOR ANALYSIS AS IT HAS YET TO BE LOCATED. THE DATA LOGS WERE NOT RETURNED, BUT THEY DO NOT PERTAIN TO THE FAILURE MODE. THE ANALYSIS AND EXAMINATION OF THE PRODUCT SHOWED AN INTERACTION BETWEEN THE IMPELLA PUMP'S REPOSITIONING UNIT AND THE GUIDEWIRE. THE GUIDEWIRE FRACTURE WAS DUE TO THE UNINTENTIONAL INSERTION OF THE PUMP REPOSITIONING UNIT INTO THE 14FR INTRODUCER, CAUSING INCREASED RESISTANCE DURING THE REMOVAL OF THE GUIDEWIRE. THE FRACTURE OF THE WIRE OCCURRED DUE TO THE EXCESSIVE FORCE APPLIED IN THE ATTEMPTED REMOVAL. A CAPA HAS BEEN OPENED TO ADDRESS THE GUIDEWIRE FAILURE MODE. FAILURES OF THIS TYPE WILL BE MONITORED AND TRENDED.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD PATIENT WITH A CARDIAC HISTORY WAS ADMITTED AND FOUND TO HAVE MULTIVESSEL CORONARY ARTERY DISEASE AND SUFFERED A VF (VENTRICULAR FIBRILLATION) EPISODE IN THE CARDIAC CATHETERIZATION LAB. HE WAS HYPOTENSIVE AND IN NEED OF HEMODYNAMIC SUPPORT FOR THE PLANNED CORONARY ANGIOPLASTY, SO AN IMPELLA CP WAS TO BE INSERTED VIA THE RIGHT FEMORAL ARTERY. THE 14FR INTRODUCER WAS PLACED, THE IMPELLA CP INSERTED, AND THE TEAM THEN ATTEMPTED TO REMOVE THE 0.018" GUIDEWIRE FROM THE IMPELLA PUMP. UPON REMOVAL THE TEAM FELT RESISTANCE FROM THE WIRE AND THE WIRE FRACTURED. THE TIP OF THE GUIDEWIRE WAS NOT OBSERVED IN THE ILIOFEMORAL ANATOMY, AORTA, OR HEART'S LEFT VENTRICLE. THE TEAM PROCEEDED WITH THE ANGIOPLASTY AND SENT THE PATIENT TO THE ICU ON SUPPORT WITH THE IMPELLA CP PUMP. PRIOR TO TRANSFER TO THE ICU THE TEAM DID A FLUOROSCOPY AND AGAIN DID NOT VISUALIZE THE TIP OF THE GUIDEWIRE. THROUGHOUT HIS HOSPITAL STAY THE TEAM DID FLUOROSCOPY AND CT IMAGING AND TO DATE HAS NOT NOTIFIED ABIOMED OF THE LOCATION OR DISCOVERY OF THE GUIDEWIRE TIP. THE PATIENT IS STILL ON SUPPORT WITH AN IMPELLA PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217331 CATHETER GUIDE WIRE CATHETER GUIDE WIRE KIT OFB ABIOMED GUIDEWIRE 0.018" PTFE COATED 1085411

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization