BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 3033421 · Received April 3, 2013

    Report

    Report Number
    2024168-2013-01946
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCORRECT REMOVAL. IT WAS INDICATED THAT THE DEVICE IS NOT RETURNING; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES WITH THE REPORTED LOT THAT COULD HAVE CONTRIBUTED TO THIS EVENT AND A QUERY OF THE COMPLAINT-HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE WARNINGS FOR USE SECTION OF THE HI-TORQUE BMW UNIVERSAL II GUIDE WIRE INSTRUCTIONS FOR USE STATES: DO NOT PUSH, AUGER, WITHDRAW OR TORQUE IF THE TIP IS NOT MANEUVERABLE, OR IT BECOMES ENTRAPPED WITHIN THE VASCULATURE AND THIS DEVICE MEETS RESISTANCE. DETERMINE THE CAUSE OF RESISTANCE AND TAKE APPROPRIATE REMEDIAL ACTION. FAILURE TO DO SO MAY RESULT IN VESSEL TRAUMA, DAMAGE / TIP SEPARATION OF THIS DEVICE, AND ALSO DAMAGE OF INTERVENTIONAL DEVICES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INDICATED THAT THE COMPLAINT DEVICE IS NOT RETURNING; HOWEVER, ONE STERILE, UNUSED, REPRESENTATIVE DEVICE WITH THE SAME PART AND LOT NUMBER AS THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING ON THE RETURNED SAMPLE DEVICE WAS PERFORMED AND THE DEVICE PASSED WITH ACCEPTABLE RESULTS. NO MANUFACTURING ISSUES OR ABNORMAL OBSERVATIONS WERE DETECTED. A CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED BASED ON THE INVESTIGATION FINDINGS FROM THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE MULTI-VESSEL ANGIOPLASTY PROCEDURE OF A PATIENT WITH PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CALCIFIED ARTERIES, A BALANCE MIDDLEWEIGHT UNIVERSAL II (BMWUII) GUIDE WIRE WAS USED; THE PHYSICIAN NOTED THE WIRE WAS LODGED IN CALCIUM AND WHEN HE PULLED AND ATTEMPTED TO REMOVE IT, A PORTION OF THE OUTER COVERING SEPARATED, LEAVING A PORTION OF THE UNRAVELED WIRE FROM THE PROXIMAL LAD INTO THE AORTA; APPROXIMATELY 30 CM IN THE PATIENT. CONSEQUENTLY, THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT (CCU) FOR OBSERVATION. IT WAS NOTED THAT THE PATIENT HAD MULTIVESSEL CORONARY ARTERY DISEASE (CAD) AND WILL AWAIT CORONARY ARTERY BYPASS GRAFT (CABG) IN THE HOSPITAL; AND ADDITIONAL INTERVENTION WILL BE PERFORMED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT INFORMATION RECEIVED STATES, "CATH LAB PROCEDURE [PERCUTANEOUS CORONARY INTERVENTION] BEING PERFORMED; HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE BEING USED IN PROCEDURE; WIRE BECAME STUCK IN ARTERY DUE TO CALCIFICATION OF ARTERY; DOCTOR ATTEMPTED TO PULL BACK GUIDE WIRE; TURBOCOAT HYDROPHILIC COATING UNRAVELED AND BROKE AWAY FROM GUIDE WIRE; COATING REMAINED IN ARTERY OF PATIENT; FURTHER INTERVENTION WILL BE REQUIRED TO REMOVE COATING FROM PATIENT ARTERY." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH, ADDITIONAL INFORMATION RECEIVED: THE DEVICE FRAGMENT WAS SUCCESSFULLY REMOVED FROM THE ANATOMY DURING CORONARY ARTERY BYPASS GRAFT PROCEDURE AND THE PATIENT WAS DISCHARGED ON AN UNSPECIFIED DATE. THE DEVICE IS BEING RETAINED BY THE SITE AND WILL NOT BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137259 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 3012971

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S