BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    MDR report key: 1892697 · Received November 3, 2010

    Report

    Report Number
    2024168-2010-02329
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    September 21, 2009
    Report Date
    October 9, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). A THOROUGH ANALYSIS ON THE PRODUCT COULD NOT BE PERFORMED, BECAUSE THE DEVICE WAS NOT RETURNED. A GUIDE WIRE SEPARATION MAY HAPPEN WHEN THE DISTAL END IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND THE DESIGN LIMITS CAUSING THE DISTAL END TO DETACH. TYPICALLY, THE FRACTURE SITE MORPHOLOGY SHOWS THE TIP WAS EXPOSED TO FORCES CONSISTENT WITH THOSE APPLIED THROUGH PULLING, TORQUING, AND/OR MANIPULATION. A WIRE BEING OVER PULLED OR OVER TORQUED WOULD REQUIRE THE WIRE TO BE TRAPPED, POSSIBLY WITHIN ANOTHER DEVICE OR IN THE ANATOMY IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE WIRE AS DESCRIBED. ANY ATTEMPTS TO MOVE A GUIDE WIRE IN A TRAPPED STATE COULD THEN RESULT IN A GUIDE WIRE SEPARATION. IN THIS CASE, IT IS POSSIBLE THE GUIDE WIRE INTERACTED WITH THE STENT AND/OR ANATOMY AND BECAME ENTANGLED AND DAMAGED DURING THE PROCEDURE AND ADDITIONAL MANIPULATION CAUSED THE WIRE TO DETACH. NO DAMAGE OR ISSUES WERE REPORTED DURING THE INITIAL PROCEDURE AND THE DETACHMENT WAS NOT NOTED UNTIL A YEAR LATER WHEN THE PATIENT COMPLAINED OF CHEST PAINS. BASED ON THE REPORTED INFORMATION, A CONCLUSIVE CAUSE FOR THE DETACHMENT OF THE GUIDE WIRE DURING THE INITIAL PROCEDURE COULD NOT BE DETERMINED, WHILE THE REPORTED PATIENT EFFECTS APPEAR TO BE A RESULT OF THE DETACHMENT. HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING PERFORMS A NON-DESTRUCTIVE TIP PULL TEST ON EACH WIRE, AND PERFORMS 100% VISUAL INSPECTION PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALANCE GUIDE WIRE WAS USED DURING A SUCCESSFUL STENTING PROCEDURE IN THE CIRCUMFLEX ARTERY. APPROXIMATELY ONE YEAR LATER, THE PATIENT PRESENTED WITH CHEST PAIN. THE PHYSICIAN FOUND 40 CM OF THE BALANCE GUIDE WIRE IN THE PATIENT'S ANATOMY, REACHING FROM THE CIRCUMFLEX TO THE DESCENDING AORTA. REPORTEDLY, THE GUIDE WIRE HAS BECOME "INGROWN" IN THE ARTERIES. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION REPORTS PERCUTANEOUS CORONARY INTERVENTION WAS SUCCESSFULLY PERFORMED ON (B)(6) 2009. ON (B)(6) 2010 ECHOCARDIOGRAPHY WAS POSITIVE AND ANGIOGRAPHY REVEALED 40 CM OF THE BALANCE GUIDE WIRE IN THE CIRCUMFLEX TO THE DESCENDING AORTA INTO THE DIAPHRAGM WITH TISSUE PROLIFERATION IN THE INNER CURVES OF THE CORONARIES INCLUDING THE LEFT MAIN. THERE WAS NO SIGNIFICANT STENOSIS. CT SCAN REVEALED THE END OF THE GUIDE WIRE IN THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other COROFLEX BLUE STENT