BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE WEB EXTRACTION BASKET

    MDR report key: 1991105 · Received February 11, 2011

    Report

    Report Number
    1037905-2011-00073
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 8, 2010
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 AND SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER INVOLVED COULD NOT BE DETERMINED. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSIONS: 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. THE INSTRUCTIONS FOR USE FOR THE CONQUEST TTC LITHOTRIPTOR CABLE INCLUDE THE FOLLOWING WARNING: DUE TO THE MECHANICAL PRESSURE GENERATED WITH THIS DEVICE, BASKET FRAGMENTATION IS A POSSIBILITY THAT MAY REQUIRE SURGICAL INTERVENTION. THE INSTRUCTIONS FOR USE FOR THE CONQUEST TTC LITHOTRIPTOR CABLE INCLUDE THE FOLLOWING WARNING: DUE TO THE VARYING COMPOSITIONS OF BILIARY STONES, STONE FRACTURE MAY NOT BE POSSIBLE. IF THE STONE CANNOT BE FRACTURED, CONTINUED ROTATION OF THE HANDLE MAY CAUSE THE BASKET WIRE TO BREAK, THUS REQUIRING SURGICAL INTERVENTION. AN AMPULLARY OPENING INADEQUATE TO ALLOW FOR THE UNIMPEDED PASSAGE OF THE STONE AND BASKET IS LISTED IN THE WEB EXTRACTION BASKET INSTRUCTIONS FOR USE AS A CONTRAINDICATION. THE PHYSICIAN MAY CHOOSE TO PERFORM A SPHINCTEROTOMY TO WIDEN THE AMPULLARY OPENING AND ALLOW PASSAGE OF THE BASKET AND OBJECT(S) FROM THE BILE DUCT (I.E. BILIARY CHANNEL) TO THE SMALL INTESTINE. PRIOR TO DISTRIBUTION, ALL WEB EXTRACTION BASKETS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: NO CORRECTIVE ACTON WARRANTED AT THIS TIME BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK WEB EXTRACTION BASKET TO PERFORM LITHOTRIPSY. THE BASKET WAS USED IN CONJUNCTION WITH A CONQUEST TTC LITHOTRIPTOR CABLE. THE BASKET WIRES BROKE NEAR THE HANDLE. THE CONQUEST TTC LITHOTRIPTOR CABLE WAS REMOVED AND A SOEHENDRA LITHOTRIPSY CABLE WAS ADVANCED OVER THE BASKET IN ANOTHER ATTEMPT AT LITHOTRIPSY. THE BASKET WIRES BROKE AGAIN. THE PT WAS SENT TO SURGERY. SEVERAL ATTEMPTS WERE MADE IN AN ATTEMPT TO COLLECT ADDITIONAL INFO REGARDING THIS OCCURRENCE. THE COMPLAINANT DID NOT SPECIFY IF THE PT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE WEB EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL FFL WILSON-COOK MEDICAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LITHOTRIPSY HANDLE (UNK TYPE)| COOK SOEHENDRA LITHOTRIPSY CABLE| ENDOSCOPE (UNK TYPE)| COOK CONQUEST TTC LITHOTRIPTOR CABLE