BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY BALLOON DILATATION CATHETER

    MDR report key: 2250209 · Received September 15, 2011

    Report

    Report Number
    3005099803-2011-03203
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K910931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO VISIBLE ISSUES WITH THE CATHETER OF THE DEVICE. HOWEVER, THROUGH FUNCTIONAL TESTING A PINHOLE WAS NOTED TO THE BALLOON MATERIAL. A SMALL TEAR WAS ALSO NOTED TO THE BALLOON MATERIAL. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE EVENT DESCRIPTION. THE REPORTED EVENT OF BALLOON INFLATION DIFFICULTY WAS CONFIRMED, AS A PINHOLE WAS NOTED TO THE BALLOON. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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 MAXFORCE BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE DUODENAL PAPILLA. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE BALLOON ONLY INFLATED A LITTLE. IT WAS REPORTED THAT THE BALLOON DID NOT BURST. THROUGH THE INVESTIGATION RESULTS, IT WAS REPORTED THAT THE BALLOON HAD A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BALLOON. 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 BILIARY BALLOON DILATATION CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00567420 13875388

    Patients

    Seq Age Sex Outcome Treatment
    1