BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCIMED PTCA BALLOON

    MDR report key: 34792 · Received July 3, 1996

    Report

    Report Number
    34792
    Event Type
    Injury
    Date Received
    July 3, 1996
    Date of Event
    June 14, 1996
    Report Date
    July 3, 1996
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS DEPLOYING A STENT. WHILE POST-DILATING STENT, PTCA BALLOON FAILED TO DEFLATE. PROXIMAL END OF BALLOON SHAFT WAS CUT WHICH ALLOWED PARTIAL DEFLATION. THE PARTIALLY DEFLATED BALLOON HAD TO BE PULLED ACROSS PROXIMAL LAD AND THE ARTERY TORE. PT BECAME UNSTABLE. BALLOON PUMP WAS PLACED. PT WAS TAKEN TO OR FOR OPEN HEART REPAIR OF DAMAGED ARTERY. PT WAS RELEASED HOME IN GOOD CONDITION ON 6/20/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCIMED PTCA BALLOON PTCA BALLOON LOX SCIMED LIFE SYSTEMS, INC. NC-BANDIT 3.0MM 518264

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| R