BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 2250213 · Received September 15, 2011

    Report

    Report Number
    3005099803-2011-03098
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K041606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED AND NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THEREFORE, A DEVICE EVALUATION HAS NOT BEEN PERFORMED AND THE REPORTED MALFUNCTION OF CATHETER BROKEN COULD NOT BE CONFIRMED. HOWEVER, IT IS POSSIBLE THE REPORTED DAMAGE OCCURRED DUE TO PROCEDURAL FACTORS SUCH AS THE LARGE STONE PRESENT IN THE DUCT; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT AN EXTRACTOR RX RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON A (B)(6) MALE PATIENT ON (B)(6), 2011 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN ATTEMPTING TO SWEEP A STONE FROM THE COMMON BILE DUCT, THE CATHETER BROKE IN TWO PIECES AT APPROXIMATELY TWO INCHES ABOVE THE BIOPSY CHANNEL. THE PHYSICIAN WAS ABLE TO WITHDRAW THE DEVICE FROM THE SCOPE. NO PIECES OF THE DEVICE DETACHED INSIDE THE PATIENT. IT WAS REPORTED THAT THIS WAS A VERY CHALLENGING CASE AND THAT THE STONE WAS UNABLE TO BE REMOVED DUE TO ITS SIZE. THEREFORE, THE PROCEDURE WAS COMPLETED BY PLACING A STENT FOR DRAINAGE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00546920 14210783

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR