BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYGLASS DIRECT VISUALIZATION SYSTEM

    MDR report key: 4100229 · Received September 18, 2014

    Report

    Report Number
    3005099803-2014-03177
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K051504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS & DELIVERY CATHETER WAS USED DURING A SPYGLASS VISUALIZATION PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS PERFORMED TO CHECK THE PLACEMENT AND LOCATION OF STRICTURES BEFORE THE PATIENT UNDERWENT A WHIPPLE PROCEDURE. IT WAS REPORTED BY THE NURSE THAT NORMAL HYGIENE ROUTINES WERE FOLLOWED AND THAT THE PROCEDURE WENT WELL. ADDITIONALLY, THERE WERE NO ISSUES NOTED WITH THE SPYSCOPE DEVICE AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. FOLLOWING THE PROCEDURE, THE PATIENT WAS DIAGNOSED WITH SEPTIC CHOLANGITIS AND PLACED ON A RESPIRATOR IN THE INTENSIVE CARE UNIT. THERE WERE NO KNOWN DEVICE ISSUES DIRECTLY RELATED TO THE PATIENT¿S POST-PROCEDURE CONDITION. THE WHIPPLE PROCEDURE HAS NOT BEEN PERFORMED DUE TO THE PATIENT¿S CHOLANGITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578464 SPYGLASS DIRECT VISUALIZATION SYSTEM ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH UNK403

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization