BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK

    MDR report key: 3675353 · Received March 7, 2014

    Report

    Report Number
    MW5034895
    Event Type
    Injury
    Date Received
    March 7, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 6, 2014
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING ANGIOGRAPHY OF RT LOWER EXTREMITY, THERE WAS SOME RESISTANCE TO ADVANCING THE BALLOON (ABBOTT VASCULAR TREK 4.0MM X 20MM, 145CM, REF 1012278-20, LOT 21012G2 RX); THEREFORE, THE BALLOON WAS PULLED OUT OF THE CROSSOVER SHEATH AND IT WAS NOTED THAT ONLY PART OF THE BALLOON THAT IS THE STIFF SHAFT CAME OUT BUT THE REST OF THE BALLOON WAS STILL IN THE LEG. UNDER FLUOROSCOPIC GUIDANCE, THE TIP OF THE BALLOON WAS FOUND TO BE IN THE MID SFA AND SO THE DECISION WAS MADE TO TRY TO RETRIEVE THAT BROKEN PIECE OF THE BALLOON. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE SHEATH WAS CHANGED INTO A 7-FRENCH LONG SHEATH THAT WAS ADVANCED INTO THE DILATED SFA AND A SNARE CATHETER WAS USED TO SNARE THE BROKEN PIECE OF THE BALLOON OUT THROUGH THE SHEATH. THE WHOLE PIECE OF THE BROKEN BALLOON WAS RETRIEVED THROUGH THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139003 TREK TREK LOX ABBOTT VASCULAR 4.00MM X 20MM, 145CM 21012G2

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention