BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE

    MDR report key: 1934818 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05152
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K922573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL INVESTIGATION RESULTS PRELIMINARY INVESTIGATION RESULTS WERE REPORTED IN THE INITIAL MDR SUBMITTED ON (B)(6), 2010. HOWEVER, THE FINAL INVESTIGATION WAS COMPLETED AND REVEALED THE FOLLOWING: VISUAL ANALYSIS OF THE RETURNED COMPLAINT DEVICE REVEALED NO VISIBLE DEFECTS. FUNCTIONAL TESTING WAS PERFORMED PER SPECIFICATION; THE SYRINGE WAS PRESSURIZED TO 10ATM WITH 35ML OF WATER FOR 30 SECONDS AND NO ISSUES WERE NOTED. BASED ON THE CONDITION OF THE RETURNED INCIDENT DEVICE, THE COMPLAINANT'S REPORT THAT THE GAUGE OF THE SYRINGE MAY HAVE BEEN READING INACCURATELY WAS NOT CONFIRMED. NO ISSUES WERE NOTED DURING THE FUNCTIONAL TESTING OF THE COMPLAINT DEVICE THAT WOULD CONFIRM THE EVENT DESCRIPTION, WHICH IS DIFFERENT THAN WHAT WAS PREVIOUSLY REPORTED IN THE INITIAL MDR. THEREFORE, THIS IS NOW NOT AN MDR REPORTABLE EVENT. ALTHOUGH THE COMPLAINT DESCRIPTION COULD NOT BE CONFIRMED, PRODUCT ANALYSIS FOUND THAT THERE WERE NO DEFECTS, A ROOT CAUSE CLASSIFICATION OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED. THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE BSC DESIGN & MANUFACTURE SPECIFICATION BUT POSSIBLY DUE TO ANATOMICAL/PROCEDURAL FACTORS DURING THE PROCEDURE PERFORMANCE WAS LIMITED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRELIMINARY INVESTIGATION RESULTS. VISUAL ANALYSIS OF THE RETURNED COMPLAINT DEVICE REVEALED NO VISIBLE DEFECTS. FUNCTIONAL TESTING WAS PERFORMED PER SPECIFICATION; THE SYRINGE WAS PRESSURIZED TO 10ATM WITH 35ML OF WATER FOR 30 SECONDS AND NO ISSUES WERE NOTED. THE REPORTED ISSUE INVOLVING THE SYRINGE AND THE BALLOON COULD NOT BE DUPLICATED. IN ADDITION, THE CONDITION OF THE BALLOON USED DURING THE PROCEDURE IS UNKNOWN AS IT WAS DISPOSED BY THE ACCOUNT. THEREFORE, IT COULD NOT BE DETERMINED THAT THE INFLATOR DID NOT MALFUNCTION FOR THE USER DURING THE PROCEDURE. IT IS POSSIBLE THAT ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMITED THE PERFORMANCE OF THE DEVICE. BASED ON THIS INFORMATION, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT AN ALLIANCE INFLATION SYRINGE AND A MAXFORCE BILIARY DILATATION BALLOON WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION PROCEDURE (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON WITHIN THE ESOPHAGUS, THE PRESSURE GAUGE OF THE SYRINGE INDICATED MAXIMUM PRESSURE, HOWEVER THE BALLOON WOULD NOT FULLY INFLATE. IT WAS UNABLE TO BE CONFIRMED WHETHER THE GAUGE OF THE SYRINGE WAS READING INACCURATELY, OR IF THE EVENT WAS DUE TO A DEFECT OF THE BALLOON, THEREFORE THIS EVENT HAS BEEN DEEMED REPORTABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT AN ALLIANCE INFLATION SYRINGE AND A MAXFORCE BILIARY DILATATION BALLOON WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION PROCEDURE (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON WITHIN THE ESOPHAGUS, THE PRESSURE GAUGE OF THE SYRINGE INDICATED MAXIMUM PRESSURE, HOWEVER THE BALLOON WOULD NOT FULLY INFLATE. IT WAS UNABLE TO BE CONFIRMED WHETHER THE GAUGE OF THE SYRINGE WAS READING INACCURATELY, OR IF THE EVENT WAS DUE TO A DEFECT OF THE BALLOON, THEREFORE THIS EVENT HAS BEEN DEEMED REPORTABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 STABLE.

    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 13611628

    Patients

    Seq Age Sex Outcome Treatment
    1 MAXFORCE TTS BILIARY DILATATION BALLOON (BSC)