BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR BALKIN GUIDING SHEATH

    MDR report key: 1932989 · Received December 15, 2010

    Report

    Report Number
    1820334-2010-00642
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 15, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED IN A USED AND DAMAGED CONDITION: THE SHEATH HAD PARTIALLY SEPARATED AT THE BASE OF THE FLARE EXPOSING THE COILS. PARTIAL ELONGATION OF THE SHEATH MATERIAL OPPOSITE THE INTACT PORTION IS EVIDENT. FLEXOR SHEATH TUBING, IN-PROCESS INSPECTION/INCOMING VENDOR INSPECTION, REQUIRES 100% INSPECTION FOR PRODUCT TO INSURE CORRECT INSIDE DIAMETER AND OUTSIDE DIAMETER OF TUBING, AND INSURE MATERIAL IS FREE FROM SURFACE DEFECTS, BUMPS, BULGES AND PROTRUDING COILS. FLEXOR CHECK-FLO II INTRODUCER, FINAL INSPECTION CONFIRMS SURFACE OF SHEATH IS FREE OF EXCESSIVE DENTS, BUMPS OR SCRATCHES. IN ADDITION, THE INSTRUCTIONS FOR USE (IFU) 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." IT IS FEASIBLE THAT REINTRODUCTION OF THE DILATOR PRIOR TO WITHDRAWAL MAY HELP TO AVOID DAMAGING THE SHEATH, ESPECIALLY IN CASES WHERE SCARRED/DISEASED ANATOMY IS PRESENT; HOWEVER, SUCH ACTIONS COULD NOT BE CONFIRMED FROM THE LIMITED PHYSICIAN'S STATEMENTS OF THE EVENT. ADDITIONALLY, ISO STANDARD 11070 REQUIRES A MINIMUM BREAK FORCE OF 3.37 LB FOR SHEATHS 5.0FR AND LARGER, WHICH HAS BEEN CONFIRMED THROUGH DESIGN VERIFICATION TESTING. PARTIAL ELONGATION OF THE SHEATH MATERIAL OPPOSITE THE INTACT PORTION MAY INDICATE A MOMENT APPLIED AT THE PROXIMAL END RESULTING IN THE SEPARATION NOTED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE ARE CONTINUING TO MONITOR FOR SIMILAR COMPLAINTS. PRIOR SIMILAR COMPLAINTS LED TO A REVISED IFU AS OF 04/16/2010, WHICH IS PRIOR TO THE POST STERILIZATION SERVICES DATE IN THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER; THEREFORE, THE OCCURRENCE RATE SINCE THIS DATE HAS BEEN CALCULATED AND THERE IS INSUFFICIENT RISK TO REQUIRE ADDITIONAL CORRECTIVE ACTION AT THIS TIME.

    Description of Event or Problem · 1

    THE VALVE OF THE INTRODUCER RIPPED AND IT LED TO MASSIVE BLEEDING. PATIENT OUTCOME AND MORE DETAILS WERE REQUESTED BUT NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR BALKIN GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA F2551668

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other