BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN

    MDR report key: 1961724 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00304
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 21, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DILATATION CATHETER: APEX OTW; INFLATION: BSC ENCORE; GUIDE CATH: CORDIS JL GUIDE WIRE SEPARATION OF THIS NATURE CAN OCCUR BUT IS NOT LIMITED TO WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE CORE TO DETACH. TYPICALLY, THE FRACTURE SITE MORPHOLOGY SHOWS THE CORE WAS EXPOSED TO FORCES CONSISTENT WITH THOSE APPLIED THROUGH PULLING, TORQUING AND/OR MANIPULATION. A GUIDE WIRE BEING OVER PULLED OR OVER TORQUED WOULD REQUIRE THE TIP TO BE TRAPPED. NO DAMAGE TO THE GUIDE WIRE WAS REPORTED PRIOR TO USE, WHICH SUGGESTS THAT THE DAMAGE WAS LIKELY NOT PRE-EXISTING. THE GUIDE WIRE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE EVALUATION. IT WAS DESCRIBED THAT THE LESION WAS HEAVILY CALCIFIED AND 90% STENOSED AND THE LESION WAS MODERATELY TORTUOUS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED INABILITY TO REMOVE AND RESULTED IN THE REPORTED GUIDE WIRE SEPARATION. THE REPORTED GUIDE WIRE SEPARATION, INABILITY TO REMOVE, REMOVAL OF FOREIGN BODY IN PATIENT, ADDITIONAL THERAPY/NON-SURGICAL TREATMENT, SURGICAL PROCEDURE AND HOSPITALIZATION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. IN ORDER TO ENSURE THAT GUIDE WIRE TIP SEPARATION DOES NOT OCCUR AS A RESULT 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 THE PATIENT WAS UNDERGOING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOGRAPHY (PTCA) IN A CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) AND LEFT CIRCUMFLEX (LCX) ARTERIES. THE BMW GUIDE WIRE BECAME TRAPPED UNDER CALCIFIED PLAQUE IN THE CALCIFIED LAD DURING THE ATTEMPT AT TREATMENT. AN ATTEMPT WAS MADE USING ANOTHER BMW GUIDE WIRE, TO TRAP THE GUIDE WIRE IN ORDER TO FACILITATE REMOVAL; HOWEVER, THIS WAS UNSUCCESSFUL. AN ATTEMPT WAS THEN MADE TO REMOVE THE GUIDE WIRE USING A BALLOON CATHETER; HOWEVER, THIS WAS ALSO UNSUCCESSFUL. RESISTANCE WAS FELT WHEN TRYING TO PULL THE GUIDE WIRE BACK, RESULTING IN THE TIP OF THE GUIDE WIRE SEPARATING. A SNARE DEVICE WAS UNABLE TO RETRIEVE THE GUIDE WIRE TIP. THE PATIENT WAS SENT FOR CORONARY ARTERY BYPASS GRAFT (CABG) TO REMOVE THE GUIDE WIRE TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN GUIDE WIRE DQX AV-TEMECULA-CT 0083171

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S