BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPYSCOPE DS ACCESS & DELIVERY CATHETER

    MDR report key: 6082482 · Received November 7, 2016

    Report

    Report Number
    3005099803-2016-03327
    Event Type
    Injury
    Date Received
    November 7, 2016
    Report Date
    October 10, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FBN
    PMA / PMN Number
    K142922
    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 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. 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 A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN STARTED TO INTRODUCE THE SPYSCOPE DS OVER THE GUIDEWIRE INTO THE PANCREAS; HOWEVER, HE LOST THE POSITION OF THE GUIDEWIRE A COUPLE OF TIMES, HENCE, HE DECIDED TO INTRODUCE THE SPYSCOPE DS TO THE SITE WITHOUT THE AID OF A GUIDEWIRE. HE WAS ABLE TO INTRODUCE THE DEVICE BUT THE PATIENT HAD PERFORATION ON THE DISTAL PART OF PANCREAS DUCT. REPORTEDLY, THERE WAS NO DEVICE MALFUNCTION AND THE PROCEDURE WAS COMPLETED USING THIS DEVICE. IN ADDITION, THE PATIENT DEVELOPED PANCREATITIS AFTERWARDS. IN THE PHYSICIAN'S ASSESSMENT, THE SPYSCOPE DS CONTRIBUTED TO THE PERFORATION OF THE PANCREATIC DUCT BUT IT IS "UNCLEAR" IF THE SPYSOPE DS ALSO CONTRIBUTED TO THE PANCREATITIS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734705 SPYSCOPE DS ACCESS & DELIVERY CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN BOSTON SCIENTIFIC - MARLBOROUGH M00546600

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention