BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLOON WEDGE CATHETER

    MDR report key: 35539 · Received July 3, 1996

    Report

    Report Number
    35539
    Event Type
    Injury
    Date Received
    July 3, 1996
    Date of Event
    May 15, 1996
    Report Date
    May 21, 1996
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RT HEART CATH VIA RT AND LF FV, RFA ANGIO PERFORMED 5/15/96. DURING OCCLUSION OF ASD WITH 7.FR BALLOON WEDGE CATHETER, BALLOON RUPTURE OCURRED FOLLOWED BY BRADYCARDIA, WIDE QRS COMPLEX, RHYTHM TO 60'S AS WELL AS HYPOTENSION TO 60-70 SYSTOLIC. PT AMBUED AND GIVEN ATROPINE AND ISUPREL WITH RESOLUTION OF WIDE QRS. ADMITTED TO ICU FOR OBSERVATION. DISCHARGED HOME 5/16/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLOON WEDGE CATHETER 7.FR 110CM WEDGE BALLOON CATHTER DYG ARROW INTERNATIONAL, INC. * IF 602832

    Patients

    Seq Age Sex Outcome Treatment
    1 31 MO Life Threatening| R