BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY BALLOON DILATATION CATHETER

    MDR report key: 1981919 · Received February 8, 2011

    Report

    Report Number
    3005099803-2011-00268
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 27, 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) RELATES TO (B)(4) FOR THE DEFECT REVEALED BY THE INVESTIGATION, BALLOON TORN. VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED NO DAMAGE TO THE CATHETER OF THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED PER SPECIFICATION, HOWEVER, A LEAK WAS NOTED IN THE BALLOON PORTION OF THE DEVICE. MICROSCOPIC EXAMINATION OF THE BALLOON REVEALED A CIRCUMFERENTIAL TEAR IN THE BALLOON MATERIAL, INDICATING THE BALLOON HAD BURST. ORIGINALLY IT WAS REPORTED THE BALLOON DID NOT INFLATE, HOWEVER, THIS IS INCONSISTENT WITH THE INVESTIGATION FINDING. THIS IS NOW A REPORTABLE EVENT. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT; THIS FAILURE OCCURS WHEN PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMIT THE PERFORMANCE OF THE BALLOON (E.G., THE BALLOON COMES INTO CONTACT WITH SHARP EXTERIOR SOURCES).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY BALLOON DILATATION CATHETERS USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00268 ADDRESSES THE FIRST MAXFORCE BALLOON, WHILE MANUFACTURER REPORT # 3005099803-2011-00269 ADDRESSES THE SECOND MAXFORCE BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT TWO MAXFORCE BILIARY BALLOON DILATATION CATHETERS WERE USED DURING A BILIARY DILATATION PROCEDURE PERFORMED ON A (B)(6) MALE PATIENT ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A JAGWIRE WAS FIRST PLACED IN THE RIGHT HEPATIC DUCT. THE COMPLAINANT REPORTED THE STRICTURE WAS "VERY TIGHT" AND THEREFORE, IT WAS DIFFICULT TO ADVANCE THE BALLOONS OVER THE GUIDEWIRE. WHEN INFLATION WAS ATTEMPTED, NEITHER BALLOON INFLATED; THE DEVICES WERE REMOVED FROM THE PATIENT. THE ACCOUNT CONFIRMED THERE WAS NO MALFUNCTION OF THE JAGWIRE. THE SAME JAGWIRE AND ANOTHER MAXFORCE BILIARY BALLOON DILATATION CATHETER WERE USED TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, THE PHYSICIAN TESTED THE TWO COMPLAINT DEVICES AND A LEAK WAS NOTED IN THE BALLOON PORTION OF EACH DEVICE; NO ADDITIONAL ISSUES WERE FOUND. 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. ON (B)(6) 2011 EVALUATION OF THE RETURNED DEVICES BY THE INVESTIGATION SITE REVEALED THE BALLOONS WERE TORN CIRCUMFERENTIALLY INDICATING THE BALLOONS HAD BURST WHICH IS CONTRARY TO THE COMPLAINANT'S REPORT THAT THE BALLOONS DID NOT INFLATE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILIARY BALLOON DILATATION CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00567340 13374531

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR