BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527

    MDR report key: 1974118 · Received January 31, 2011

    Report

    Report Number
    3005099803-2011-00138
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOG
    PMA / PMN Number
    K010610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE (B)(6). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS BEING TREATED FOR STONES WITHIN THE COMMON BILE DUCT. DURING THE ERCP PROCEDURE, THE NURSE REPORTED THAT WHEN THE PHYSICIAN ADVANCED A HYDRATOME SPHINCTEROTOME THROUGH THE BIOPSY CAP, THE SPONGE IN THE BIOPSY CAP BECAME DISLODGED WITHIN THE WORKING CHANNEL OF THE OLYMPUS 160 SCOPE. THE PATIENT WAS RESCOPED, AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS USING A OLYMPUS SCOPE BIOPSY CAP ALONG WITH THE SAME HYDRATOME SPHINCTEROTOME. NO PATIENT COMPLICATIONS WERE 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 13883582

    Patients

    Seq Age Sex Outcome Treatment
    1