BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE

    MDR report key: 1778653 · Received July 31, 2010

    Report

    Report Number
    3005099803-2010-03225
    Event Type
    Malfunction
    Date Received
    July 31, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K922573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: A VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE DEVICE WAS FROM LOT 2073142 AND REVEALED NO VISUAL DEFECTS. FUNCTIONAL TESTING WAS COMPLETED PER SPECIFICATION; THE DEVICE WAS ATTEMPTED TO BE PRESSURIZED TO 10 ATM, HOWEVER THE GAUGE DID NOT MOVE. THEREFORE, THE INVESTIGATION CONFIRMED THE COMPLAINANT'S REPORT THAT THE PRESSURE GAUGE DID NOT WORK. AS THE EVENT OCCURRED DURING THE PROCEDURE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT; THIS FAILURE OCCURS WHEN PROCEDURAL FACTORS ENCOUNTERED LIMIT THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4) (GAUGE, INACCURATE READINGS).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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT AN ALLIANCE INFLATION SYRINGE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON A (B)(6) MALE PATIENT ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE BALLOON WAS INFLATED WITH THE SYRINGE, HOWEVER THE GAUGE FAILED TO REGISTER PRESSURE; THE NEEDLE WAS STUCK AT ZERO. THE ACCOUNT REPORTED THAT THE SAME BALLOON AND ANOTHER ALLIANCE INFLATION SYRINGE WERE USED TO COMPLETE THE PROCEDURE. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT AN ALLIANCE INFLATION SYRINGE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON A (B)(6) MALE PATIENT ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE BALLOON WAS INFLATED WITH THE SYRINGE, HOWEVER THE GAUGE FAILED TO REGISTER PRESSURE; THE NEEDLE WAS STUCK AT ZERO. THE ACCOUNT REPORTED THAT THE SAME BALLOON AND ANOTHER ALLIANCE INFLATION SYRINGE WERE USED TO COMPLETE THE PROCEDURE. 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 FINE.

    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 2073142

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR