BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1810315 · Received August 20, 2010

    Report

    Report Number
    3005099803-2010-03590
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K041606
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE MODEL, CATALOG NUMBER AND LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. (B)(4) - NO CODE AVAILABLE (MEDICAL INTERVENTION REQUIRED). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. NOTE: FROM THE DIRECTIONS FOR USE (DFU) DOCUMENT: THE EXTRACTOR¿ RX RETRIEVAL BALLOON IS INDICATED FOR USE ENDOSCOPICALLY TO REMOVE STONES FROM THE BILIARY SYSTEM, OR TO FACILITATE INJECTION OF CONTRAST MEDIUM WHILE OCCLUDING THE DUCT WITH THE BALLOON.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 30, 2010 THAT AN EXTRACTOR RX RETRIEVAL BALLOON (DEVICE MODEL, CATALOG NUMBER, AND LOT NUMBER UNKNOWN) WAS USED TO CLEAR AN OBSTRUCTED WALLFLEX BILIARY FC STENT DURING A PROCEDURE PERFORMED ON (B)(6) 2010 (THE OBSTRUCTION EVENT IS ADDRESSED BY MANUFACTURER REPORT # 3005099803-2010-03056). ACCORDING TO THE COMPLAINANT, A CHOLANGIOGRAM PERFORMED ON (B)(6) 2010 REVEALED THE STENT WAS OCCLUDED WITH FOOD AND DEBRIS. THE CHOLANGIOGRAM ALSO REVEALED MILD NARROWING AT THE COMMON HEPATIC DUCT (THERE WAS DEBRIS IN THE RIGHT HEPATIC DUCT). ON (B)(6) 2010, WHILE ATTEMPTING TO CLEAR THE STENT WITH AN EXTRACTOR RX RETRIEVAL BALLOON, THE STENT "FELL OUT." THE STENT WAS REMOVED WITH GRASPING FORCEPS, AND THERE WERE NO COMPLICATIONS DURING THE STENT REMOVAL. AFTER CLEARING THE DEBRIS FROM BOTH HEPATIC DUCTS, A PLASTIC STENT WAS PLACED. THERE WAS NO ALLEGED MALFUNCTION OF THE EXTRACTOR RX RETRIEVAL BALLOON USED IN THE PROCEDURE. ON (B)(6) 2010, 7 DAYS POST STENT REMOVAL, THE PATIENT HAD ELEVATED BILIRUBIN LEVELS. AN ERCP WAS PLANNED FOR (B)(6) 2010. THE PHYSICIAN ASSESSED THE ELEVATED BILIRUBIN LEVELS AS POSSIBLY RELATED TO THE WALLFLEX BILIARY FC STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK UNK161

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other