BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEMORY HARD WIRE BASKET

    MDR report key: 19948714 · Received August 9, 2024

    Report

    Report Number
    1037905-2024-00448
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 15, 2024
    Report Date
    September 3, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FFL
    UDI-DI
    10827002220024
    PMA / PMN Number
    K851965
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A FOLLOW-UP EMDR WILL BE SUBMITTED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A WHITE PLASTIC BAG. PROVIDED WITH THE RETURN WAS AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. THE PHOTOS PROVIDED SHOW THE REPORTED DEVICE COILED WITHIN AN OPEN POUCH, THE HANDLE AND BASKET ARE BOTH IN THE "ADVANCED" POSITION. IT IS UNCLEAR FROM THE PHOTO WHAT THE STATE OF THE DISTAL CATHETER IS OR IF DAMAGE IS PRESENT. THE LOT NUMBER PROVIDED IN THE PHOTOS MATCHES THIS REPORT. THE LABEL IN THE PHOTO MATCHES THE PRODUCT REPORTED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE RETURNED WITH THE BASKET FULLY ADVANCED. A VISUAL INSPECTION OF THE BASKET FOUND IT TO BE FULLY FORMED AND INTACT. A VISUAL INSPECTION OF THE CATHETER FOUND THE DISTAL CATHETER WAS TWISTED AND COMPRESSED 206.3CM TO 209.5CM DISTAL TO THE HANDLE. WITH THE CATHETER RELAXED ON THE TABLETOP, RESISTANCE WAS ENCOUNTERED DURING RETRACTION WHEN THE BASKET WAS PARTIALLY RETRACTED. THE RESISTANCE WAS NOTED TO OCCUR AS THE BASKET'S PROXIMAL METAL TUBING PASSED THROUGH A PARTICULARLY COMPRESSED LOCATION, 206.9CM DISTAL TO THE HANDLE, AND RESOLVED ONCE THE METAL TUBING WAS PAST THE COMPRESSED PORTION. RESISTANCE WAS NOTED DURING ADVANCEMENT AS THE METAL TUBING PASSED THROUGH THE SAME COMPRESSED AREA AS WELL. FRICTION CAN BE FELT AS THE DRIVE WIRE MOVES THROUGH OUT THE COMPRESSED PORTION AS WELL DURING BOTH ADVANCEMENT AND RETRACTION. THE BASKET WAS ADVANCED THROUGH AN ENDOSCOPE WITH A WORKING CHANNEL 2.8 MM IN DIAMETER (OLYMPUS 2.8 GIF Q20 ENDOSCOPE), THE DEVICE WAS ABLE TO BE SUCCESSFULLY ADVANCED AND RETRACTED WITH HANDLE MANIPULATION AND EXPERIENCED THE SAME RESISTANCE PREVIOUSLY ENCOUNTERED AS THE METAL TUBING PASSED THROUGH THE COMPRESSED AREA. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. 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 PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT, THE DISTAL END OF THE CATHETER HAS BEEN COMPRESSED AND TWISTED RESULTING IN RESISTANCE DURING ADVANCEMENT AND RETRACTION OF THE BASKET. THE ADDITIONAL INFORMATION INDICATES THAT THE BASKET EXTENSION AND RETRACTION WAS VERIFIED, AND FUNCTIONED PROPERLY, PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. 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. THE INSTRUCTIONS FOR USE INDICATES: "ADVANCE DEVICE THROUGH CHANNEL IN SHORT INCREMENTS UNTIL BASKET SHEATH EXITS ENDOSCOPE." BASKET DEPLOYMENT DIFFICULTIES AND BUCKLING/BREAKING OF THE DRIVE WIRE CAN OCCUR IF THE DEVICE EXPERIENCES EXCESSIVE PRESSURE. RESISTANCE IN BASKET MOVEMENT AND BENDS IN THE CATHETER CAN OCCUR IF THE ELEVATOR OF THE ENDOSCOPE IS USED TO DEFLECT THE DEVICE AT A SHARP ANGLE. PRIOR TO DISTRIBUTION, ALL MEMORY HARD WIRE BASKET 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. 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.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK MEMORY HARD WIRE BASKET. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND ADVANCED THE DEVICE THROUGH THE ENDOSCOPE TO THE BILE DUCT TO REMOVE THE STONE AND THE DEVICE COULD NOT BE RETRACTED. THE USER DETECTED THE TIP OF THE SHEATH WAS KINKED AFTER REMOVING THE STONE FROM THE PATIENT. USER CHANGED TO ANOTHER DEVICE TO CONTINUE THE PROCEDURE. 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
    1636272 MEMORY HARD WIRE BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL FFL WILSON-COOK MEDICAL INC G22002 W4664565 10827002220024

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female OLYMPUS ENDOSCOPE