BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE

    MDR report key: 1904575 · Received November 22, 2010

    Report

    Report Number
    3005099803-2010-04892
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    September 14, 2010
    Report Date
    November 4, 2010
    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. 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. VISUAL EVALUATION OF THE COMPLAINT DEVICE REVEALED THE NEEDLE OF THE GAUGE WAS NOT INDICATED AT ZERO. THIS DEFECT WAS NOT NOTED BY THE ACCOUNT; THEREFORE, IT IS MOST PROBABLE THE DAMAGE OCCURRED DURING TRANSPORT OF THE DEVICE FROM THE ACCOUNT TO THE INVESTIGATION SITE. FUNCTIONAL TESTING WAS PERFORMED PER SPECIFICATION. THE DEVICE WAS PRESSURIZED TO 10ATM FOR 30 SECONDS, AND NO LEAKS WERE NOTED. THEREFORE, THE COMPLAINT THAT A LEAK WAS NOTED AT THE LUER OF THE SYRINGE COULD NOT BE CONFIRMED; HOWEVER, IT IS POSSIBLE THAT THE LUER LEAKED DURING THE EVENT DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT 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 WAS USED DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2010 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A LEAK WAS NOTED AT THE LUER OF THE SYRINGE. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; GAUGE READING INACCURATELY.

    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 13576224

    Patients

    Seq Age Sex Outcome Treatment
    1