BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    MDR report key: 19498500 · Received June 10, 2024

    Report

    Report Number
    1037905-2024-00319
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 10, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    ODC
    UDI-DI
    00827002596832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K213483. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE INFORMATION PROVIDED INDICATED A COOK DELTA WIRE GUIDE WAS USED WHICH IS A FULLY HYDROPHILIC COATED WIRE GUIDE. THE IFU STATES: "FOR OPTIMAL PERFORMANCE, UTILIZE DEVICE WITH NON-FULLY HYDROPHILIC COATED .025" AND .035" COOK WIRE GUIDES." THIS IS THE MOST LIKELY CAUSE FOR THE REPORTED DIFFICULTY. 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: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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. ADDITIONAL COMMENTS: BASED ON THE INFORMATION PROVIDED THAT A COOK DELTA WIRE GUIDE WAS USED WHICH IS A FULLY HYDROPHILIC COATED WIRE GUIDE, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK SNAPLOCK WIRE GUIDE LOCKING DEVICE. IT WAS REPORTED THAT "THE WIRE KEPT 'BUCKLING-OUT' [WIRE LOOPING AT THE SNAPLOCK] DURING WIRE EXCHANGES. THE PHYSICIAN SWITCHED TO A COMPETITORS SPHINCTEROTOME AND WIRE GUIDE DEVICE TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY." THE INFORMATION PROVIDED INDICATED THAT A COOK WIRE GUIDE WAS USED AND LATER REPLACED WITH A COMPETITORS WIRE GUIDE. THIS IS BEING INTERPRETED AS LOSS OF WIRE GUIDE ACCESS. [SUBJECT OF REPORT]. 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
    653408 SNAPLOC WIRE GUIDE LOCKING DEVICE ODC ENDOSCOPE CHANNEL ACCESSORY ODC WILSON-COOK MEDICAL INC W4827300 00827002596832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male BOSTON SCIENTIFIC DREAM WIRE GUIDE.| BOSTON SCIENTIFIC DREAM TOME.| COOK DELTA WIRE GUIDE.| COOK OMNITOME.| ENDOSCOPE, UNKNOWN MAKE AND MODEL.