BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMORY SOFT WIRE BASKET

    MDR report key: 2992214 · Received March 1, 2013

    Report

    Report Number
    1037905-2013-00081
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 30, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. INSTRUCTIONS FOR USE STATE: "DUE TO MECHANICAL PRESSURE GENERATED WITH SOEHENDRA LITHOTRIPTOR, BASKET FRAGMENTATION AND/OR STONE IMPACTION IN COMMON BILE DUCT MAY OCCUR." PRIOR TO DISTRIBUTION, ALL MEMORY SOFT WIRE BASKETS 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 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.

    Description of Event or Problem · 1

    SEVERAL BASKETS WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). A COOK MEMORY SOFT WIRE BASKET WAS USED. AN ATTEMPT WAS MADE TO MANUALLY FRACTURE THE STONE WITH THE BASKET, BUT THIS WAS UNSUCCESSFUL. MECHANICAL LITHOTRIPSY HAD TO BE USED. THE COOK MEMORY SOFT WIRE BASKET WAS USED IN CONJUNCTION WITH A COOK SOEHENDRA LITHOTRIPTOR CABLE. DURING MECHANICAL LITHOTRIPSY, THE TIP OF THE BASKET BROKE AND DETACHED INSIDE THE PATIENT. THERE WAS NO SEPARATION OF BASKET WIRES; ONLY THE BASKET TIP POPPED OFF. THE BASKET RETRACTED BACK INTO THE SOEHENDRA LITHOTRIPTOR CABLE DURING USE. THEY ATTEMPTED TO CAPTURE THE BASKET TIP WITH ANOTHER BASKET BUT THIS WAS UNSUCCESSFUL. THE BASKET TIP WAS LEFT INSIDE THE PATIENT AND A PIGTAIL STENT WAS PLACED DUE TO RESIDUAL STONE DEBRIS. A SECOND PROCEDURE WILL BE PERFORMED TO REMOVE THE STENT AND REMAINING DEBRIS. IF THE BASKET TIP IS STILL THERE, IT WILL BE REMOVED DURING THE SECOND PROCEDURE. THE PHYSICIAN INDICATED THE BASKET TIP MAY PASS NATURALLY THROUGH THE GASTROINTESTINAL TRACT ON ITS OWN. THE PATIENT IS DOING WELL. ACCORDING TO THE AREA REPRESENTATIVE, NO ADVERSE EFFECTS AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89275 MEMORY SOFT WIRE BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL FFL WILSON-COOK MEDICAL INC W2941102

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention SOEHENDRA LITHOTRIPTOR| OLYMPUS TJF 160-F ENDOSCOPE