BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE

    MDR report key: 2163031 · Received July 15, 2011

    Report

    Report Number
    3005099803-2011-02421
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K922573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. HOWEVER, IT WAS REPORTED THE PATIENT IS (B)(6). (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE FOUND GAUGE COVER WAS COATED WITH WHAT APPEARED TO BE CONTRAST MEDIA. THE GAUGE COVER WAS CLEANED USING ALCOHOL AND IT WAS NOTED THAT THERE WAS ABRASION MARKS ON THE FACE OF THE GAUGE COVER. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE EVENT DESCRIPTION, HOWEVER, THE "STEAM" WAS NOT CONFIRMED. THE REPORTED DEFECT THE GAUGE COVER BEING "TARNISHED" WAS CONFIRMED AS THERE WERE ABRASIONS MARKS ON THE FACE OF THE GAUGE COVER. THE COMPLAINT WAS CAUSED BY HANDLING OF THE DEVICE WITHOUT PATIENT CONTACT EITHER DURING THE CLINICAL PROCEDURE OR UNPACKING/PREPARATION. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE INFLATION SYRINGE WAS TO BE USED DURING AN EPBD (ENDOSCOPICALLY PERFORMED BILIARY DRAINAGE) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINT, AFTER UNPACKING, THE CLEAR PLASTIC COVER OF THE SYRINGE GAUGE WAS FOUND TO BE DISCOLORED AND HAD THE APPEARANCE OF "STEAM." REPORTEDLY, THE METER WAS VISIBLE, BUT THIS CONDITION MADE THE GAUGE DIFFICULT TO READ. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE INFLATION SYRINGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE INFLATION SYRINGE WAS TO BE USED DURING AN EPBD (ENDOSCOPICALLY PERFORMED BILIARY DRAINAGE) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINT, AFTER UNPACKING, THE CLEAR PLASTIC COVER OF THE SYRINGE GAUGE WAS FOUND TO BE DISCOLORED AND HAD THE APPEARANCE OF "STEAM." REPORTEDLY, THE METER WAS VISIBLE, BUT THIS CONDITION MADE THE GAUGE DIFFICULT TO READ. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE INFLATION SYRINGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M00550601 14114932

    Patients

    Seq Age Sex Outcome Treatment
    1