BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BIOPSY CAP AND LOCKIND DEVICE #4526 & 4527

    MDR report key: 4061462 · Received September 4, 2014

    Report

    Report Number
    3005099803-2014-02956
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOG
    PMA / PMN Number
    K010610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18 THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE AND BIOPSY CAP WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE PATIENT'S COMMON BILE DUCT ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, WHEN THE STENT PASSED THROUGH THE BIOPSY CAP, THE SPONGE FROM THE BIOPSY CAP WAS DETACHED AND BECAME STUCK IN THE STENT. NO VISIBLE ISSUE WITH THE COMPLAINT DEVICE OR THE PACKAGING WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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
    541524 RAPID EXCHANGE BIOPSY CAP AND LOCKIND DEVICE #4526 & 4527 ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - SPENCER M00545260

    Patients

    Seq Age Sex Outcome Treatment
    1