BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAPLOC WIRE GUIDE LOCKING DEVICE

    MDR report key: 19350933 · Received May 20, 2024

    Report

    Report Number
    1037905-2024-00272
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 24, 2024
    Report Date
    May 20, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    ODC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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 DELTA GUIDE WIRE 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. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED 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 DELTA GUIDE WIRE 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 DOCTOR CLAIMS THAT IT [THE DEVICE] IS NOT HOLDING HIS WIRE. HE CLAIMS THAT HE LOST WIRE [GUIDE] ACCESS [SUBJECT OF REPORT]. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. 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
    1672691 SNAPLOC WIRE GUIDE LOCKING DEVICE ODC ENDOSCOPE CHANNEL ACCESSORY ODC WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown COOK OMNI TOME - UNKNOWN MODEL.| DELTA GUIDE WIRE, UNKNOWN MODEL.| ENDOSCOPE, UNKNOWN MAKE AND MODEL.