BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR INTRODUCER SHEATH

    MDR report key: 2090074 · Received May 5, 2011

    Report

    Report Number
    1820334-2011-00220
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 6, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INTRODUCER SHEATH AND DILATOR WERE RETURNED IN A USED AND DAMAGED CONDITION. AN EXAMINATION CONFIRMED THE SHEATH HAD SEPARATED ABOUT 10CM FROM THE TIP WITH NO EVIDENCE OF TUBING ELONGATION. IT WAS NOTED THAT THE COIL HAD UNRAVELLED AND THE DISTAL 10CM SEGMENT WAS TO RETURNED. THE CONDITION OF THE DILATOR WAS UNREMARKABLE. IN QUALITY CONTROL IN-PROCESS INSPECTION/INCOMING VENDOR INSPECTION, THERE IS 100% INSPECTION, INSURING CORRECT INSIDE AND OUTSIDE DIAMETER OF TUBING. IN ADDITION, IT IS VERIFIED THAT THE MATERIAL IS FREE FROM SURFACE DEFECTS, BUMPS, BULGES AND PROTRUDING COILS. THE SURFACE OF SHEATH IS CONFIRMED TO BE FREE OF EXCESSIVE DENTS, BUMPS OR SCRATCHES DURING QUALITY CONTROL FINAL INSPECTION. THIS PRODUCT IS SUPPLIED WITH AN IFU THAT CAUTIONS THE END USER, "ALL CATHETERS AND INSTRUMENTS USED WITH THIS INTRODUCER SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. SEPARATION OF THE SHEATH MAY RESULT WHEN THE FIT IS TIGHT." AS WELL AS THE WARNING. "BEFORE WITHDRAWING THE SHEATH THROUGH TORTUOUS ANATOMY, INSERT THE INTRODUCER DILATOR TO AVOID POSSIBLE BREAKAGE." BASED ON THE PHYSICIAN'S STATEMENT, IT APPEARS THE FAILURE MODE DESCRIBED WAS DUE TO PT ANATOMY AND POTENTIALLY THE FAILURE TO REINSERT THE DILATOR PRIOR TO SHEATH WITHDRAWAL AS STATED IN THE IFU, "BEFORE WITHDRAWING THE SHEATH THROUGH TORTUOUS ANATOMY, INSERT THE INTRODUCER DILATOR TO AVOID POSSIBLE BREAKAGE." THE ROOT CAUSE OF THIS EVENT IS BELIEVED TO BE PROCEDURAL/PT CONDITION RELATED. PRIOR SIMILAR COMPLAINTS AND RISK ANALYSIS RESULTED IN THE INSURANCE OF A CORRECTIVE ACTION/PREVENTATIVE ACTION FOR THIS FAILURE MODE OF SEPARATION. THE CAPA LED TO A REVISED IFU ISSUED VIA CHANGE REQUEST, IMPLEMENTED ON APRIL 16, 2010; WHICH IS ASSUMED TO BE PRIOR TO THE POST STERILIZATION SERVICES DATE FOR THIS DEVICE. ALTHOUGH NO LOT NUMBER WAS PROVIDED, THE OCCURRENCE RATE (SINCE THIS DATE) HAS BEEN CALCULATED; WHICH REVEALED THERE IS INSUFFICIENT RISK, TO REQUIRE ADD'L CORRECTIVE ACTION AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE VERIFIED THE EFFECTIVENESS OF IMPLEMENTING THE DESCRIBED CORRECTIVE/PREVENTIVE ACTION. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS NOT ABLE TO ESTABLISH CONTRALATERAL ACCESS TO THE LEFT ARTERY DUE TO THE ACUTE ANGLE OF THE ILIAC BIFURCATION. THE SHEATH WAS WITHDRAWN FROM THE ARTERY AND HE NOTICED THAT THE TIP OF THE SHEATH HAD BROKEN INSIDE THE PT AND WAS LOCATED IN THE RIGHT SFA. THE PT HAD A FEM-STOP DEVICE PLACED ON THE INSERTION SITE AND WAS TRANSFERRED TO VASCULAR SURGERY WHERE THE TIP OF THE SHEATH WAS REMOVED. THE RIGHT LEG IS NOW OCCLUDED. IT IS NOT KNOWN WHEN THE OCCLUSION OCCURRED; DURING THE INITIAL INTERVENTION, DURING OR FOLLOWING THE SURGERY. THE PT HAD EXCELLENT LEG PRESSURES PRIOR THE FIRST INTERVENTION AND THEY CANNOT DETERMINE IF LEG PRESSURES WERE TAKEN POST SURGERY. THE PHYSICIAN TOLD THE COOK MED SALES REP, THAT THE REASON FOR THIS EVENT WAS NOT A PRODUCT FAILURE. IT WAS BECAUSE OF THE PT'S CONDITION (4X SURGERY BEFORE) AND THE RESULTING EXTREMELY SCARRED TISSUE. ALSO HE STATED THAT IT MIGHT BE BETTER IF HE HAD INSERTED THE DILATOR BEFORE PULLING OUT THE INTRODUCER TO AVOID THIS EVENT. NO INFO REGARDING PT OUTCOME WAS PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR INTRODUCER SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention