BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 3232258 · Received July 9, 2013

    Report

    Report Number
    1820334-2013-00254
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    COOK, INC.
    Product Code
    KRD
    PMA / PMN Number
    K123712
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT CODE: LEAVING A PORTION OF THE WIRE IN THE PT IS NOT LABELED IN THE IFU. ONE DAMAGED DELIVERY WIRE WAS RETURNED. ONLY THE MANDRILL WAS RETURNED AS THE INCONEL COIL PORTION OF THE DELIVERY WIRE REMAINS ATTACHED TO THE EMBOLIZATION COIL WHICH IS IMPLANTED. EVIDENCE OF SOLDER WAS VISIBLE ON THE MANDRILL WIRE SUGGESTING THAT THE DEVICE WAS MANUFACTURED TO SPEC. THE SOLDERS ARE VERIFIED TO BE SECURE IN THE MFG PROCESS. QUALITY CONTROL (QA) VERIFIES THAT SOLDERS ARE SECURE AND GAUGE SOLDERS. PROCESS VALIDATION WAS COMPLETED FOR THE SOLDERING OF THE MWCER DELIVERY WIRE AND A STUDY TESTED THE TENSILE STRENGTH OF THE DELIVERY WIRE. THE PRODUCT IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) WHICH PROVIDES THE WARNINGS, PRECAUTIONS AND INSTRUCTIONS FOR USE. WITHOUT EXAMINATION OF THE PORTION OF THE DELIVERY WIRE THAT REMAINS IMPLANTED IN THE PT, IT IS DIFFICULT TO DETERMINE WITH CERTAINTY WHAT MAY HAVE LED TO THIS FAILURE MODE. HOWEVER, IT IS POSSIBLE THAT THE DELIVERY WIRE WAS EXPOSED TO TENSILE FORCES BEYOND ITS DESIGN LEADING TO DEVICE SEPARATION. AS THE PORTION OF THE DELIVERY WIRE THAT SEPARATED REMAINED ATTACHED TO THE EMBOLIZATION COIL IT REMAINS IMPLANTED IN THE PT. THE EMBOLIZATION COIL/DELIVERY WIRE SEGMENT WAS PACKED IN WITH THE OTHER EMBOLIZATION COILS ALREADY IN PLACE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL. THIS IS THE FIRST OCCURRENCE OF THIS FAILURE MODE SO NO ADD'L ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    WHERE THE COIL IS SUPPOSED TO BE ATTACHED AT THE JUNCTION, IT DETACHED PROXIMAL TO THAT JUNCTION. WHERE THE INCONEL SURROUNDS THE NITINOL WIRE IS WHERE THE COIL DETACHED LEAVING THE JUNCTION AND SOME OF THE WIRE IN THE PT. THE WIRE FRAGMENTS WERE LEFT IN THE PT. THE WIRE HOLDING THE COIL BROKE OFF. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313736 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK, INC. NA 4234371

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other