BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    MDR report key: 11685458 · Received April 19, 2021

    Report

    Report Number
    1820334-2021-01157
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 5, 2021
    Report Date
    April 19, 2021
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002311190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER NAME AND ADDRESS: PHONE: (B)(6); POSTAL: (B)(6). COMMON NAME & PRODUCT CODE = ALTHOUGH THIS SPECIFIC RPN IS NOT MARKETED IN THE US, SIMILAR RPNS ARE MARKETED IN THE US BY CINC. THE PRODUCT CODE FOR THOSE DEVICES IS DYB. PMA/510(K) NUMBER = ALTHOUGH THIS SPECIFIC RPN IS NOT MARKETED IN THE US, SIMILAR RPNS ARE MARKETED IN THE US BY CINC. THE 510(K) FOR THOSE DEVICES IS K142819. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. FROM THE DEVICE ANALYSIS, A HOLE WAS CONFIRMED JUST DISTAL TO THE PROXIMAL HUB. NO OTHER DAMAGE WAS NOTED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FROM THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, DHF, IFU, AND RETURNED PRODUCT, COOK CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. THE PRODUCT IFU WARNS, "INSERT THE DILATOR COMPLETELY INTO THE SHEATH". BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A COMPONENT FAILURE CONTRIBUTED TO THE FAILURE MODE. IT IS POSSIBLE THAT EITHER A KINK IN THE SHEATH OR ADVANCING THE SHEATH OVER THE WIRE GUIDE WITHOUT A DILATOR PRESENT COULD HAVE CONTRIBUTED TO THE HOLE, HOWEVER NEITHER OF THESE COULD BE CONFIRMED. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    AS REPORTED, DURING A CEREBROVASCULAR TREATMENT PROCEDURE, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH WOULD NOT FULLY ADVANCE OVER AN UNKNOWN WIRE GUIDE. ACCESS WAS GAINED IN THE RIGHT FEMORAL ARTERY. THE USER THEN ATTEMPTED TO INSERT THE SHEATH OVER THE WIRE GUIDE, BUT THE WIRE STUCK AT THE HUB AND WOULD NOT COME OUT OF THE "HAND PART". ANOTHER DEVICE OF THE SAME TYPE WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE PACKAGE, WHICH WAS STORED VERTICALLY. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, A HOLE WAS NOTED ON THE SHEATH, BELOW THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588472 FLEXOR SHUTTLE TIBIAL GUIDING SHEATH DYB COOK INC STK10005029X 00827002311190

    Patients

    Seq Age Sex Outcome Treatment
    1