BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVER BALLOON DILATATION CATHETER

    MDR report key: 165707 · Received May 4, 1998

    Report

    Report Number
    6000047-1998-00003
    Event Type
    Injury
    Date Received
    May 4, 1998
    Date of Event
    October 21, 1996
    Report Date
    April 7, 1998
    Manufacturer
    MICROVASIVE ENDOSCOPY A DIV OF BOSTON SCIENTIFIC CORP.
    Product Code
    KNQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A PERFORATION OCCURRED DURING A DUODENAL PROCEDURE ON OCTOBER 21, 1996 IN WHICH THIS BALLOON CATHETER WAS USED. NO BALLOON MALFUNCTION WAS REPORTED. NO FURTHER DETAILS ARE AVAILABLE WITH REGARDS TO THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD FURTHER INFO BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH REPORT WILL BE FORWARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVER BALLOON DILATATION CATHETER GL BALLOON DIL CATH KNQ MICROVASIVE ENDOSCOPY A DIV OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other