BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DSB-DETACHABLE SILICONE BALLOON

    MDR report key: 267126 · Received March 2, 2000

    Report

    Report Number
    6000078-2000-00011
    Event Type
    Malfunction
    Date Received
    March 2, 2000
    Date of Event
    January 26, 2000
    Report Date
    March 2, 2000
    Manufacturer
    TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TARGET WAS NOTIFIED THAT DURING THE TREATMENT OF A VERTEBRAL FISTULA, THE DSB RUPTURED PRIOR TO DETACHMENT. THERE WAS NO CONSEQUENCE FOR THE PT, WHO WAS SUCCESSFULLY TREATED WITH ANOTHER DSB AND GDC COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DSB-DETACHABLE SILICONE BALLOON DETACHABLE BALLOON HCG TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORP. NA A73062

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO TYPE OF DEVICE: DELIVERY CATHETER, CATALOG#| 2. BRAND NAME: GDC-18 COIL, TYPE OF DEVICE:| 1. BRAND NAME: DSB-DETACHABLE SILICONE BALLOON,| 750160, LOT# A73396.| TYPE OF DEVICE: DELIVERY CATHETER, CATALOG#| 5. BRAND NAME: COAXIAL ANGIOGRAPHIC CATHETER SET,| 750160, LOT# A73396.| 881853, LOT #: A73062, EXPIRATION DATE: 05-2001,| DETACHABLE COIL, CATALOG# 352520-3, EXPIRATION| 4. BRAND NAME: COAXIAL ANGIOGRAPHIC CATHETER SET,| DETACHABLE COIL, IMPLANT DATE: 01/26/2000.| 3. BRAND NAME: GDC COIL, TYPE OF DEVICE:| DATE: 12-2001.| TYPE OF DEVICE: DETACHABLE BALLOON, CATALOG #: