BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, TRANSLUMINAL BALLOON

    MDR report key: 3180290 · Received June 20, 2013

    Report

    Report Number
    3005099803-2013-04910
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    October 4, 2012
    Report Date
    May 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GBA
    PMA / PMN Number
    K781772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND NO ISSUES. WHEN A FUNCTIONAL TEST WAS PERFORMED, IT WAS NOTED THAT THE GAUGE WAS READING 2 PSI LOW. THE NEEDLE WAS RESET AT 20 PSI AND THE COMPLAINT SAMPLE WAS RE-TESTED AND FOUND TO WORK WITHIN SPECIFICATIONS. THIS FAILURE MOST LIKELY WAS CAUSED BY JARRING OF THE DEVICE DURING HANDLING POST PROCEDURE OR SHIPPING BACK TO BSC OR THE EXTERNAL MANUFACTURER FOR ANALYSIS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PNEUMATIC INFLATION DEVICE WAS USED DURING AN ACHALASIA BALLOON DILATATION PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE INFLATOR PRESSURE PUMP BECAME STUCK AND STAYED IN THE CONTRACTED FORM, CAUSING IT TO BE DIFFICULT TO INFLATE. THE PROCEDURE WAS ABLE TO COMPLETED WITH THIS 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. INVESTIGATION RESULTS REVEALED THE GAUGE WAS READING INACCURATELY, THEREFORE THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280262 CATHETER, TRANSLUMINAL BALLOON CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MARLBOROUGH M00553200

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR