BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPE MANDRIL WIRE GUIDE

    MDR report key: 5194762 · Received November 2, 2015

    Report

    Report Number
    1820334-2015-00695
    Event Type
    Injury
    Date Received
    November 2, 2015
    Date of Event
    September 15, 2015
    Report Date
    October 9, 2015
    Manufacturer
    COOK INC
    Product Code
    DXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: A DIMENSIONAL VERIFICATION, ALONG WITH A REVIEW OF THE COMPLAINT HISTORY, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS AND A VISUAL EXAMINATION OF THE RETURNED PRODUCT WAS CONDUCTED DURING THE INVESTIGATION. THE VISUAL EXAMINATION DETERMINED: DEVICE WAS RETURNED IN AN USED CONDITION DEVICE CONSISTED OF TWO PIECES, ONE WAS COIL ONLY AND THE OTHER WAS MANDRIL WITH COIL. COIL ONLY PIECE MEASURED 18 CM. MANDRIL WITH COIL MEASURED 110CM (MANDRIL 54CM, COIL 56CM). THE PROVIDED LOT RECORDS (LOT 5930825) OF THE DEVICE WERE REVIEWED AND NO ISSUES CONCERNING THE QUALITY OF THE PRODUCT RELATIVE TO THIS INVESTIGATION WERE NOTED. THE MANUFACTURING AND QUALITY CONTROL DEPARTMENTS PERFORM A 100% INSPECTION, VERIFYING EACH DEVICE IS FREE FROM BENDS, KINKS, HAS ADEQUATE JOINT STRENGTH, CORRECT OUTSIDE DIMENSION AND OTHER SURFACE IMPERFECTIONS PRIOR TO TRANSPORT. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    WHEN THE COPE MANDRIL WIRE GUIDE WAS BEING REMOVED FROM THE PATIENT'S SUBCLAVIAN VEIN, THE END CAME OFF. THE PHYSICIAN WAS ABLE TO REMOVE THE FRAGMENTED PIECE WITH NO HARM TO THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    WHEN THE COPE MANDRIL WIRE GUIDE WAS BEING REMOVED FROM THE PATIENT'S SUBCLAVIAN VEIN, THE END CAME OFF. THE PHYSICIAN WAS ABLE TO REMOVE THE FRAGMENTED PIECE WITH NO HARM TO THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726942 COPE MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DXQ COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1