BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATEWAY¿

    MDR report key: 2213087 · Received August 16, 2011

    Report

    Report Number
    2939204-2011-00400
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 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. MAGNIFIED INSPECTION OF THE RETURNED BALLOON CATHETER REVEALED A HOLE IN THE INNER SHAFT DIRECTLY ALIGNED WITH THE INFLATION PORT. THE INNER SHAFT WAS APPROPRIATELY SEATED IN THE HUB AND THERE WAS ADHESIVE PRESENT IN THE ADHESIVE CAVITY. THERE WERE NO OTHER ANOMALIES FOUND. 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. THE HOLE IN THE INNER SHAFT WAS MOST LIKELY CAUSED BY A PERFORATION WITH A NEEDLE OR A GUIDEWIRE USED DURING PREPARATION AS NO TOOLS ARE INSERTED IN THE MANIFOLD INFLATION PORT DURING CATHETER ASSEMBLY. FURTHERMORE, ALL DEVICES ARE TESTED FOR BALLOON INFLATION/DEFLATION PERFORMANCE WITH VACUUM DECAY TESTING DURING MANUFACTURE. FROM THE INFORMATION PROVIDED AND THE INVESTIGATION RESULTS THE HOLE IN THE CATHETER INNER SHAFT WAS MOST LIKELY RELATED TO THE MANNER THE DEVICE WAS HANDLED. THEREFORE, A ROOT CAUSE OF HANDLING DAMAGE HAS BEEN ASSIGNED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THAT A LUER-LOCK SYRINGE WITH 3 ML (CC) OF CONTRAST MEDIUM WAS USED TO FLUSH THE DEVICE. AFTER SEVERAL ATTEMPTS TO FLUSH THE DEVICE, THERE WERE STILL AIR BUBBLES COMING OUT OF THE BALLOON DURING ASPIRATION.

    Description of Event or Problem · 1

    DURING PREPARATION IT WAS FOUND THAT THE BALLOON LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    DURING PREPARATION IT WAS FOUND THAT THE BALLOON LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY¿ CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MAPLE GROVE M0032072415200 14020521

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR