BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527

    MDR report key: 1830072 · Received September 10, 2010

    Report

    Report Number
    3005099803-2010-03855
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOG
    PMA / PMN Number
    K010610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE AND BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE PASSING A DEVICE THROUGH THE BIOPSY CAP OF THE RX LOCKING DEVICE AND BIOPSY CAP, THE SPONGE WAS PUSHED OUT OF THE BIOPSY CAP AND BECAME LODGED WITHIN THE SCOPE CHANNEL. THE FOAM SPONGE BLOCKED ANOTHER DEVICE FROM ADVANCING THROUGH THE SCOPE. ATTEMPTS TO REMOVE THE SPONGE FROM THE SCOPE WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX LOCKING DEVICE AND BIOPSY CAP AND ANOTHER SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - SPENCER M00545261

    Patients

    Seq Age Sex Outcome Treatment
    1