BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    MDR report key: 20945625 · Received December 16, 2024

    Report

    Report Number
    1037905-2024-00813
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 21, 2024
    Report Date
    January 9, 2025
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    ODC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K213483 INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PICTURES AND VIDEO PROVIDED WITH THIS REPORT BECAUSE THE PRODUCTS SAID TO BE INVOLVED WERE NOT PROVIDED TO COOK FOR EVALUATION. DEVICE #1: OUR EVALUATION OF THE PHOTOS AND VIDEO PROVIDED CONFIRMED THE REPORT. THE VIDEO SHOWS THE WIRE GUIDE MOVING/SLIPPING THROUGH THE WIRE LOCK WITHOUT DIFFICULTY. THE PHOTOS SHOW THE DISTAL END OF THE SCOPE AND DEVICE LABELING FOR A BOSTON SCIENTIFIC JAGWIRE. ADDITIONALLY, A PHOTO WAS PROVIDED OF THE SNAPLOC-O POUCH; THE LOT NUMBER PROVIDED IN THE PHOTO MATCHES THIS REPORT. THE LABEL IN THE PHOTO MATCHES THE PRODUCT REPORTED. DEVICE #2: OUR EVALUATION OF THE PHOTOS PROVIDED COULD NOT CONFIRM THE REPORT. THE PHOTOS SHOW THE DEVICE LABELING FOR A BOSTON SCIENTIFIC DREAMWIRE AND BOSTON SCIENTIFIC RAPID EXCHANGE XL CANNULA. ADDITIONALLY, A PHOTO WAS PROVIDED OF THE SNAPLOC-O POUCH; THE LOT NUMBER PROVIDED IN THE PHOTO MATCHES THIS REPORT. THE 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: DEVICE #1: OUR EVALUATION OF THE PHOTOS 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. DEVICE #2: 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: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K213483. INVESTIGATION EVALUATION: ONE OF THE PRODUCTS SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BAG. PROVIDED WITH THE RETURN WAS AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. ADDITIONALLY, A BOSTON SCIENTIFIC JAGWIRE AND POUCH WAS PROVIDED IN THE RETURN. THE RETURNED SNAPLOC-O HAS BEEN IDENTIFIED AS DEVICE #1 BASED ON THE INCLUDED ACCESSORY (BOSTON SCIENTIFIC JAGWIRE). DEVICE #1: OUR EVALUATION OF THE PHOTOS AND VIDEO PROVIDED CONFIRMED THE REPORT. THE VIDEO SHOWS THE WIRE GUIDE MOVING/SLIPPING THROUGH THE WIRE LOCK WITHOUT DIFFICULTY. THE PHOTOS SHOW THE DISTAL END OF THE SCOPE AND DEVICE LABELING FOR A BOSTON SCIENTIFIC JAGWIRE. ADDITIONALLY, A PHOTO WAS PROVIDED OF THE SNAPLOC-O POUCH; THE LOT NUMBER PROVIDED IN THE PHOTO MATCHES THIS REPORT. THE LABEL IN THE PHOTO MATCHES THE PRODUCT REPORTED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT REPRODUCE THE REPORT AS IT WAS DESCRIBED. THE DEVICE WAS RETURNED WITH NO DAMAGE NOTED TO THE DEVICE. THE DEVICE WAS FUNCTIONAL TESTED BY PLACING THE SNAPLOC-O ONTO AN OLYMPUS SCOPE AND THE RETURNED JAGWIRE WAS ABLE TO BE ADVANCED AND RETRACTED THROUGH THE WIRE LOCK WITHOUT RESISTANCE, BUT WOULD REMAIN IN PLACE WHEN IDLE. THE WIRE CLICKED INTO THE LOCKING POSITION AND WHEN PULLED TO THE SIDE THE WIRE WAS ONLY ABLE TO BE MOVED WITH NOTABLE FORCE ON BOTH SIDES OF THE WIRE LOCK. DIMPLING WAS NOTED ON THE COATING OF THE GUIDEWIRE FOLLOWING BEING PULLED THROUGH THE LOCK, AND IT IS BELIEVED THIS IS EVIDENCE OF THE WIRE LOCK APPLYING FORCE ONTO THE WIRE WHILE IN THE LOCKED POSITION. NO OTHER ANOMALIES WERE DETECTED WITH THE DEVICE. DEVICE #2: OUR EVALUATION OF THE PHOTOS PROVIDED COULD NOT CONFIRM THE REPORT. THE PHOTOS SHOW THE DEVICE LABELING FOR A BOSTON SCIENTIFIC DREAMWIRE AND BOSTON SCIENTIFIC RAPID EXCHANGE XL CANNULA. ADDITIONALLY, A PHOTO WAS PROVIDED OF THE SNAPLOC-O POUCH; THE LOT NUMBER PROVIDED IN THE PHOTO MATCHES THIS REPORT. THE 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: DEVICE #1: OUR EVALUATION OF THE PHOTOS AND VIDEO PROVIDED CONFIRMED THE REPORT. HOWEVER, WE COULD NOT REPRODUCE THE FAILURE DURING OUT EVALUATION. A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. DEVICE #2: 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: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 0

    DURING TWO SEPARATE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES, THE PHYSICIAN USED TWO (2) COOK SNAPLOC WIRE GUIDE LOCKING DEVICES, ONE IN EACH PROCEDURE. IN BOTH CASES, ANOTHER MANUFACTURERS WIRE GUIDE WOULD SLIP WHILE IT WAS LOCKED DURING USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312294 SNAPLOC WIRE GUIDE LOCKING DEVICE ODC ENDOSCOPE CHANNEL ACCESSORY ODC WILSON-COOK MEDICAL INC G59683 W4840754

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BOSTON DREAMWIRE ANGLED TIP 0.035 INCH 260CM| BOSTON RAPID EXCHANGE CATHETER| JAGWIRE STRAIGHT TIP WIRE GUIDE 0.035 INCH 450CM| OLYMPUS DUODENOSCOPE 190 SERIES| OLYMPUS PEDIATRIC COLONOSCOPE 3.2