BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    MDR report key: 20665201 · Received November 12, 2024

    Report

    Report Number
    1037905-2024-00713
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 18, 2024
    Report Date
    November 12, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    ODC
    UDI-DI
    00827002596832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K213483. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PHOTO AND VIDEO PROVIDED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. OUR EVALUATION OF THE PHOTO AND VIDEO PROVIDED CONFIRMED THE REPORT. THE VIDEO SHOWS THE DEVICE REMOVED FROM THE SCOPE WITH A WIRE GUIDE ADVANCED THROUGH IT. THE USER SHOWS THAT WHEN ATTEMPTING TO LOCK THE WIRE GUIDE ON EITHER SIDE IT REMAINS ABLE TO SLIP IN AND OUT OF THE WIRE LOCK. THE PHOTO SHOWS MICRO LABELS FROM PRODUCTS INVOLVED IN THE PROCEDURE, INCLUDING A MICRO LABEL FROM LOT NUMBER PROVIDED IN THE PHOTO MATCHES THIS REPORT. THE MICRO LABEL IN THE PHOTO MATCHES THE PRODUCT REPORTED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: OUR EVALUATION OF THE PHOTO AND VIDEO PROVIDED CONFIRMED THE REPORT. HOWEVER, WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL SNAPLOC WIRE GUIDE LOCKING DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK SNAPLOC WIRE GUIDE LOCKING DEVICE. IT WAS REPORTED THAT THE WIRE GUIDE SLIPPED WHEN REMOVING THE TOME - THE WIRE MOVED OUT WITH IT EVEN THOUGH IT WAS LOCKED. THE PHYSICIAN WAS USING BOSTON 0.035 STANDARD WIRE GUIDE. A VIDEO WAS PROVIDED OF THE WIRE BEING LOCKED ON BOTH SIDES OF THE SNAPLOC SHOWING THE WIRE SLIPPING WHILE LOCKED. AT THE TIME OF THIS REPORT, OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME HAVE BEEN UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED. ADDITIONAL ATTEMPTS TO GATHER THIS INFORMATION WILL BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540973 SNAPLOC WIRE GUIDE LOCKING DEVICE ODC ENDOSCOPE CHANNEL ACCESSORY ODC WILSON-COOK MEDICAL INC G59683 W4840744 00827002596832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BOSTON SCIENTIFIC 0.035 STANDARD WIRE GUIDE| BOSTON SCIENTIFIC SPHINCTEROTOME| ENDOSCOPE, UNKNOWN MAKE AND MODEL