BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATEWAY BALLOON CATHETER

    MDR report key: 2010681 · Received March 8, 2011

    Report

    Report Number
    2939204-2011-00104
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    GBA
    PMA / PMN Number
    H050001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE BALLOON CATHETER WAS RETURNED FOR ANALYSIS. A PERFORATION WAS FOUND ON THE BACK WALL OF THE PROXIMAL INNER SHAFT UNDER THE MANIFOLD OPPOSITE THE INFLATION LUMEN. THE BALLOON CATHETER COULD NOT BE PREPPED DUE TO THE INNER LEAK UNDER THE MANIFOLD. THIS PERFORATION WAS MOST LIKELY CAUSED BY A NEEDLE/SYRINGE SYSTEM OR A GUIDE WIRE USED DURING PREPARATION. NO TOOLS ARE INSERTED IN THE MANIFOLD INFLATION PORT DURING CATHETER ASSEMBLY. IT IS EXTREMELY UNLIKELY THAT INNER DAMAGE CAUSED DURING ASSEMBLY WOULD LINE UP DIRECTLY WITH THE INFLATION PORT ON THE MANIFOLD. THE DEVICE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT OR THE CONFIRMED DAMAGE TO THE DEVICE. THOUGH THE EXACT CAUSE OF THE DAMAGE WAS NOT DETERMINED, THE DAMAGE MAY BE ATTRIBUTABLE TO HANDLING OF THE DEVICE DURING UNPACKING AND/OR PREPARATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY. FROM THE RESPONSES RECEIVED, IT WAS DETERMINED THAT THERE WAS NO DAMAGES TO THE PACKAGING OR REMOVING THE DEVICE FROM THE DISPENSER HOOP. A 2ML SYRINGE WAS USED TO FLUSH THE DEVICE AND NO HOLES WERE NOTED TO THE DEVICE.

    Description of Event or Problem · 1

    WHEN THE DEVICE WAS FLUSHED DURING PREPARATION, IT WAS NOTED THAT THE BALLOON WAS LEAKING. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE USE OF ANOTHER DEVICE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 1

    WHEN THE DEVICE WAS FLUSHED DURING PREPARATION, IT WAS NOTED THAT THE BALLOON WAS LEAKING. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE USE OF ANOTHER DEVICE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY BALLOON CATHETER CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MAPLE GROVE M0032072409220 12619655

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR