BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDEFLATOR

    MDR report key: 1220664 · Received November 3, 2008

    Report

    Report Number
    MW5008844
    Event Type
    Injury
    Date Received
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INDEFLATOR BROKE -MADE A SINGLE "POP" SOUND WHILE A STENT WAS INFLATED IN THE CORONARY ARTERY AND THEN WE WERE NOT ABLE TO PULL BACK THE HANDLE ON IT TO DEFLATE THE STENT. WE WERE ABLE TO QUICKLY DISCONNECT THE INDEFLATOR FROM THE STENT/BALLOON CATHETER AND DEFLATE THE BALLOON BY PULLING A NEGATIVE WITH A 20CC SYRINGE. THIS CAUSED A SLIGHT DELAY IN DEFLATING THE BALLOON BUT NO MORE THAN A FEW SECONDS, AND THERE WAS NO ADVERSE REACTIONS FOR THE PATIENT WITNESSED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDEFLATOR NONE MAV ABBOTT VASCULAR 8092393

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability