BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATW MARKER GUIDEWIRE

    MDR report key: 3912410 · Received July 3, 2014

    Report

    Report Number
    1016427-2014-00075
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 9, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) A 300CM. SGW ATW STR FLOPPY MARKER GUIDEWIRE ¿BROKE OFF¿ IN THE PATIENT¿S VASCULATURE. ATTEMPTS TO REMOVE THE SEPARATED PIECE OF GUIDEWIRE WERE UNSUCCESSFUL. THE PATIENT IS REPORTED TO BE ¿DOING FINE¿ THE PROCEDURE WAS A PCI INVOLVING LESIONS IN THE LEFT ANTERIOR DESCENDING (LAD), CIRCUMFLEX AND RAMUS ARTERIES. AN UNKNOWN 7F LONG SHEATH WAS USED IN CONJUNCTION WITH A CORDIS 7F XB3.5 GUIDE CATHETER. THREE ATW WIRES WERE USED DURING BALLOON ANGIOPLASTY OF THE RAMUS. UPON COMPLETION OF THE PROCEDURE, A PIECE OF AN ATW MARKER GUIDEWIRE SEPARATED IN THE DISTAL PORTION OF THE PATIENT¿S RAMUS ARTERY. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10357749. THIS PACKAGING LOT CONTAINED (B)(4) UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL LIMITED ON JANUARY 20, 2014. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL LIMITED AND WAS DETERMINED TO BE ACCEPTABLE. WITHOUT RETURN OF THE DEVICE FOR ANALYSIS OR PROCEDURAL FILMS OF THE EVENT, THE REPORTED COMPLAINT ¿DISTAL TIP-FRACTURED/SEPARATED IN PATIENT¿ COULD NOT BE CONFIRMED AND AN EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS ARE UNKNOWN BUT MAY HAVE BEEN A CONTRIBUTING FACTOR IN THE REPORTED ISSUE. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT THE PHYSICIAN WAS PERFORMING A PERCUTANEOUS CORONARY INTERVENTION (PCI) INVOLVING THE LEFT ANTERIOR DESCENDING (LAD), CIRCUMFLEX AND RAMUS TARGET LESIONS. A 7F LONG SHEATH WAS USED IN THE PROCEDURE ALONG WITH A 7F XB3.5 GUIDE CATHETER. THREE SEPARATE GUIDEWIRES WERE USED TO ACCESS ALL THREE TARGET LESIONS. THE PHYSICIAN ADVANCED THE 300 CM. SGW ATW STR FLOPPY MARKER GUIDEWIRE DOWN THE RAMUS AND PERFORMED BALLOON ANGIOPLASTY. AFTER, HE NOTICED A PIECE OF THE ATW MARKER GUIDEWIRE HAD BROKEN OFF AND REMAINS TODAY IN THE PATIENT¿S VESSEL (DISTAL). THE PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN PIECE OF WIRE USING VARIOUS TECHNIQUES, BUT REMOVAL WAS NOT ACHIEVED. THE PATIENT IS CURRENTLY DOING FINE BUT THE PHYSICIAN HAS CONCERNS ABOUT WHETHER THIS VESSEL WILL CLOT AND BE OCCLUDED. THE PHYSICIAN REVIEWED FILMS WITH THE CLINICAL SPECIALIST AND PROVIDED A PRINT-OUT SHOWING THE GUIDEWIRE BROKEN INSIDE THE VESSEL. THE PRODUCT WAS RETURNED TO CLINICAL SPECIALIST BUT THE ACCOUNT HAS REQUESTED THE WIRE TO BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391778 ATW MARKER GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 35220869

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R 7F XB3.5 GUIDE CATHETER, UNKNOWN 7 FR. LONG SHEATH