BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDSB-NON DETACHABLE SILICON BALLOON

    MDR report key: 350981 · Received August 21, 2001

    Report

    Report Number
    6000078-2001-00052
    Event Type
    Malfunction
    Date Received
    August 21, 2001
    Date of Event
    January 22, 2001
    Report Date
    August 21, 2001
    Manufacturer
    TARGET THERAPEUTICS, A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BSC/TARGET THAT AFTER FLUSHING THE INTRODUCER DURING PREPERATION, THE BALLOON IN THE ENDEAVOR DID NOT PASS THROUGH. THE MINIMAL LUMEN FOR THAT BALLOON MATCH THE SPEC OF THE INTRODUCER, BUT IT WAS STUCK INSIDE. A SECOND SET WAS OPENED AND A SECOND BALLOON WAS REINTERVENTED WITH 8 FXF GUIDER. CLINICAL OUTCOME - NO TEMPORARY OCCLUSION. UPON EVALUATION IT WAS DISCOVERED THAT THE NDSB HAD BEEN RUPTURED THEREFORE THE COMPLAINT BECAME AN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38651 NDSB-NON DETACHABLE SILICON BALLOON NON DETACHABLE OCCLUSION BALLOON HCG TARGET THERAPEUTICS, A DIVISION OF BOSTON SCIENTIFIC CORP. * A75194

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO BRAND NAME: 1. ENDEAVOR NDSB, CATALOG #: 781552,| LOT#: A67067, EXPIRATION DATE: 05/01/2001.| NAME: 2. INTRODUCER CATHETER, CATALOG #: 790270,| LOT#: 2966227, EXPIRATION DATE: 02/28/2002. BRAND