BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 2122419 · Received June 13, 2011

    Report

    Report Number
    3005099803-2011-02081
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    March 9, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K041606
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRATION. (B)(4) - THE REPORTED EVENT OF CATHETER TIP DETACHMENT. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    CORRECTION: REQUIRED INTERVENTION.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO EXTRACTOR RX BALLOONS USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02066 ADDRESSES THE FIRST BALLOON, WHILE MANUFACTURER REPORT # 3005099803-2011-02081 ADDRESSES THE SECOND BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT TWO EXTRACTOR RX RETRIEVAL BALLOONS WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND STONE RETRIEVAL PROCEDURE PERFORMED ON (B)(6), FEMALE PATIENT ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS EXCHANGING THE BALLOONS OVER THE GUIDEWIRE, THE TIPS OF EACH EXTRACTOR BALLOON CATHETER DETACHED IN THE COMMON BILE DUCT. THE PROCEDURE WAS NOT COMPLETED AT THIS TIME; HOWEVER THE PATIENT WAS REPORTED TO BE OKAY AT THE CONCLUSION OF THE PROCEDURE. IT WAS PLANNED TO PERFORM A REPEAT ERCP AND CHOLECYSTECTOMY THE FOLLOWING DAY. ON (B)(6) 2011, A REPEAT ERCP AND CHOLECYSTECTOMY WAS PERFORMED. DURING THIS PROCEDURE, STONES AND SLUDGE WERE REMOVED AND THE DETACHED TIPS WERE SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE (UNKNOWN MODEL/UPN). THE PATIENT'S CONDITION AT THE CONCLUSION OF THE SECOND PROCEDURE WAS REPORTED TO BE OKAY.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO EXTRACTOR RX BALLOONS USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02066 ADDRESSES THE FIRST BALLOON, WHILE MANUFACTURER REPORT # 3005099803-2011-02081 ADDRESSES THE SECOND BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT TWO EXTRACTOR RX RETRIEVAL BALLOONS WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND STONE RETRIEVAL PROCEDURE PERFORMED ON AN (B)(6) YEAR-OLD, 190-POUND, FEMALE PATIENT ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS EXCHANGING THE BALLOONS OVER THE GUIDEWIRE, THE TIPS OF EACH EXTRACTOR BALLOON CATHETER DETACHED IN THE COMMON BILE DUCT. THE PROCEDURE WAS NOT COMPLETED AT THIS TIME; HOWEVER, THE PATIENT WAS REPORTED TO BE OKAY AT THE CONCLUSION OF THE PROCEDURE. IT WAS PLANNED TO PERFORM A REPEAT ERCP AND CHOLECYSTECTOMY THE FOLLOWING DAY. ON (B)(6), 2011, A REPEAT ERCP AND CHOLECYSTECTOMY WAS PERFORMED. DURING THIS PROCEDURE, STONES AND SLUDGE WERE REMOVED AND THE DETACHED TIPS WERE SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE (UNKNOWN MODEL/UPN). THE PATIENT'S CONDITION AT THE CONCLUSION OF THE SECOND PROCEDURE WAS REPORTED TO BE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00546910

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention