BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 2032057 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02087
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. INDICATION FOR USE, EXCESSIVE FORCE. THE HI TORQUE WHISPER GUIDE WIRE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. GUIDE WIRE TIP SEPARATION MAY OCCUR WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL OVERLOAD BEYOND THE DESIGN LIMITS CAUSING THE DISTAL TIP 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 WIRE BEING OVER PULLED OR OVER TORQUED THAT WOULD REQUIRE THE TIP TO BE TRAPPED, IN THIS CASE, WITHIN THE ANATOMY IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE WIRE AS DESCRIBED ABOVE. REPORTEDLY, THE VESSEL WAS DESCRIBED AS A TIGHT TURN WHICH COULD HAVE CONTRIBUTED TO THE GUIDE WIRE INABILITY TO CROSS THE LESION AND POSSIBLY RESULT IN THE GUIDE WIRE TO BE TANGLED AND SEPARATED. ADDITIONALLY, IT WAS REPORTED THAT EXCESSIVE FORCE WAS APPLIED DURING PROCEDURAL ATTEMPTS TO CROSS THE LESION. THE INSTRUCTIONS FOR USE (IFU) STATES, DO: 1. ADVANCE OR WITHDRAW THE GUIDE WIRE SLOWLY. 2. EXAMINE THE TIP MOVEMENT UNDER FLUOROSCOPY BEFORE MANIPULATING, MOVING OR TORQUING THE GUIDE WIRE. FAILURE TO DO SO MAY RESULT IN VESSEL TRAUMA, GUIDE WIRE DAMAGE, GUIDE WIRE TIP SEPARATION, OR STENT DAMAGE. IF RESISTANCE IS OBSERVED AT ANY TIME, DETERMINE THE CAUSE UNDER FLUOROSCOPY AND TAKE REMEDIAL ACTION AS NEEDED. IT IS UNKNOWN WHETHER THE USE OF EXCESSIVE FORCE DURING ADVANCEMENT CONTRIBUTED TO THE REPORTED GUIDE WIRE SEPARATION. ADDITIONALLY, IT WAS REPORTED THAT THE GUIDE WIRE WAS USED IN AN ELECTROPHYSIOLOGY PROCEDURE AND IT SHOULD BE NOTED IN THE IFU: ALL HI-TORQUE GUIDE WIRES ARE INTENDED TO FACILITATE THE PLACEMENT OF BALLOON DILATATION CATHETERS DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND PERCUTANEOUS TRANLUMINAL ANGIOPLASTY (PTA). IT IS UNKNOWN WHETHER THE USE OF THE GUIDE WIRE IN AN ELECTROPHYSIOLOGY PROCEDURE CONTRIBUTED TO THE REPORTED GUIDE WIRE SEPARATION. REPORTEDLY, ANOTHER WHISPER GUIDE WIRE WAS USED TO ADVANCE INTO THE CORONARY SINUS AND THE SAME ISSUE OCCURRED. ADDITIONALLY, NO INTERVENTION WAS PERFORMED TO RETRIEVE THE DETACHED TIPS FROM THE ANATOMY. IN ORDER TO ENSURE THAT INABILITY TO CROSS THE LESION, TANGLED GUIDE WIRE AND GUIDE WIRE SEPARATION DOES NOT OCCUR AS A RESULT OF A PRODUCT QUALITY DEFICIENCY, MANUFACTURING PERFORMS VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER IT IS LOADED INTO THE DISPENSER, PERFORMS OUTER DIAMETER INSPECTION AND PERFORMS A NON DESTRUCTIVE TIP PULL TEST OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY. THE REPORTED INABILITY TO CROSS THE LESION, TANGLED GUIDE WIRE AND GUIDE WIRE SEPARATION APPEAR TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGY PROCEDURE IN THE CORONARY SINUS, THE PHYSICIAN WAS ATTEMPTING TO MAKE A TIGHT TURN DURING ADVANCEMENT OF THE WHISPER GUIDE WIRE. EXCESSIVE TORQUE WAS APPLIED. AFTER THE TURN WAS MADE, THE TIP OF THE GUIDE WIRE SEEMED TO BECOME TANGLED. AN ATTEMPT WAS MADE TO WITHDRAW THE GUIDE WIRE INTO THE GUIDING CATHETER; HOWEVER, THE TIP OF THE GUIDE WIRE SHEARED OFF. ANOTHER WHISPER GUIDE WIRE WAS ADVANCED INTO THE CORONARY SINUS AND THE SAME OCCURRED. NO INTERVENTION WAS PERFORMED TO RETRIEVE THE DETACHED TIPS FROM THE ANATOMY. THE PATIENT IS REPORTED AS STABLE; HOWEVER, THE PROCEDURE WAS PROLONGED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 1010501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other