BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE

    MDR report key: 2122352 · Received June 13, 2011

    Report

    Report Number
    3005099803-2011-01971
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 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

    INVESTIGATION RESULTS VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE FOUND THE GAUGE NEEDLE STUCK AT 5 ATM. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE EVENT DESCRIPTION. THE REPORTED DEFECT OF GAUGE READING INACCURATELY WAS CONFIRMED. THE ROOT CAUSED OF THIS COMPLAINT IS HANDLING DAMAGE, AS THE COMPLAINT WAS CAUSED BY HANDLING OF THE DEVICE WITHOUT PATIENT CONTACT EITHER DURING THE CLINICAL PROCEDURE OR UNPACKING/PREPARATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT AN ALLIANCE INFLATION DEVICE WAS USED DURING A BALLOON INFLATION PROCEDURE PREFORMED ON A PATIENT ON (B)(6), 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINT, DURING PREPARATION, THE NURSE DROPPED THE DEVICE FROM 60-70 CM. AFTER THE NURSE PICKED THE DEVICE UP, THE DEVICE CONSTANTLY READ 5 ATM WHEN NO PRESSURE WAS APPLIED TO THE DEVICE. THE USER REPORTED THAT THERE WAS NO DAMAGE TO THE NEEDLE OF THE GAUGE. HOWEVER WHEN PRESSURE WAS APPLIED OVER 5 ATM THE NEEDLE WOULD INCREASE IN PRESSURE. THE USER SAID THE PRESSURE GAUGE WAS NOT READING CORRECTLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE 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 ON (B)(6), 2011 THAT AN ALLIANCE INFLATION DEVICE WAS USED DURING A BALLOON INFLATION PROCEDURE PREFORMED ON A PATIENT ON (B)(6), 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINT, DURING PREPARATION, THE NURSE DROPPED THE DEVICE FROM 60-70 CM. AFTER THE NURSE PICKED THE DEVICE UP, THE DEVICE CONSTANTLY READ 5 ATM WHEN NO PRESSURE WAS APPLIED TO THE DEVICE. THE USER REPORTED THAT THERE WAS NO DAMAGE TO THE NEEDLE OF THE GAUGE. HOWEVER WHEN PRESSURE WAS APPLIED OVER 5 ATM THE NEEDLE WOULD INCREASE IN PRESSURE. THE USER SAID THE PRESSURE GAUGE WAS NOT READING CORRECTLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE 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 14097005

    Patients

    Seq Age Sex Outcome Treatment
    1