BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATEWAY BALLOON CATHETER

    MDR report key: 2063205 · Received April 19, 2011

    Report

    Report Number
    2939204-2011-00209
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 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

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY. FROM THE RESPONSES RECEIVED, IT WAS DETERMINED THAT NO DAMAGE WAS NOTED TO THE PACKAGING, THE DISPENSER HOOP WAS FLUSHED WITH SALINE AND NO DIFFICULTIES WERE EXPERIENCED REMOVING THE DEVICE FROM THE DISPENSER HOOP.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS. THE BALLOON WAS PRESSURIZED TO NOMINAL PRESSURE (6ATM) AND HELD FOR 5 MINUTES. MAGNIFIED INSPECTION INSIDE THE INFLATION PORT REVEALED NO LEAKING OR DAMAGE TO THE SHAFT. PRODUCT ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED EVENT. THE MANUFACTURING CONTROLS IN PLACE FOR BALLOON LEAKS INCLUDE MULTIPLE 100% VISUAL INSPECTIONS FOR DAMAGE AND 100% PROCESSING THROUGH LEAK AND VACUUM DECAY TESTING. BASED ON ANALYSIS OF THE DEVICE AND AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED, THEREFORE A ROOT CAUSE OF 'NOT CONFIRMED' WAS ASSIGNED. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENTS OF A REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    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 PATIENT INVOLVEMENT.

    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 PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY BALLOON CATHETER CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MAPLE GROVE M0032072409200 13218489

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR