BEUDAMED
    FDA Adverse Event Other Summary report: N

    XPEEDIOR THROMBECTOMY SET

    MDR report key: 1943810 · Received December 20, 2010

    Report

    Report Number
    2183460-2010-00009
    Event Type
    Other
    Date Received
    December 20, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 20, 2010
    Manufacturer
    MEDRAD INTERVENTIONAL / POSSIS
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A BROKEN DEVICE DURING ANGIOJET THERAPY. THE PT IS A MALE OF UNK AGE AND UNK MEDICAL HISTORY WHO WAS UNDERGOING A PERIPHERAL ARTERIAL PROCEDURE FOR TREATMENT OF ACUTE LIMB ISCHEMIA WITH AN ANGIOJET ULTRA THROMBECTOMY SET. DURING THE PROCEDURE, THE ANGIOJET DEVICE BROKE INSIDE AN OCCLUDED VESSEL. THE PHYSICIAN RETRIEVED THE DISTAL PORTION OF THE CATHETER BY SNARING IT INTO A SHEATH AND THEN PULLING THE SHEATH OUT FROM THE PT. THE PT HAD NO SEQUELAE AS A RESULT OF THIS EVENT. THE IFU WARNS THE USER: "DO NOT PULL THE CATHETER AGAINST ABNORMAL RESISTANCE. IF INCREASED RESISTANCE IS FELT WHEN REMOVING THE CATHETER, REMOVE THE CATHETER TOGETHER WITH THE SHEATH OR GUIDE CATHETER AS A UNIT TO PREVENT POSSIBLE TIP SEPARATION." "IF RESISTANCE IS FELT DURING THE ADVANCEMENT OF THE THROMBECTOMY SET TO LESION SITE, DO NOT FORCE OR TORQUE THE CATHETER EXCESSIVELY AS THIS MAY RESULT IN DEFORMATION OF TIP COMPONENTS AND THEREBY DEGRADE CATHETER PERFORMANCE." THIS EVENT IS CONSIDERED A REPORTABLE EVENT AS INTERVENTION WAS REQUIRED TO RETRIEVE THE DISTAL PORTION OF THE BROKEN CATHETER.

    Description of Event or Problem · 1

    DURING A PERIPHERAL ARTERIAL WITH ACUTE LIMB ISCHEMIA CASE. THE DISTAL TIP OF THE XPEEDIOR CATHETER BROKE OFF INSIDE OCCLUDED VESSEL. PHYSICIAN HAD TO USE A SHEATH TO SNARE THE CATHETER TIP AND SUCCESSFULLY RETRIEVED AND REMOVED THE BROKEN PIECE FROM THE PT. ESTIMATED DELAY TIME WAS ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPEEDIOR THROMBECTOMY SET ULTRA XPEEDIOR DXE MEDRAD INTERVENTIONAL / POSSIS 105040-001 99182

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention