BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PILOT GUIDE WIRE

    MDR report key: 1961242 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00285
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    November 16, 2010
    Report Date
    December 24, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT PERFORMANCE ENGINEERING HAS REVIEWED THE CASE DESCRIPTION, HOWEVER, THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. FOR THE WIRE TO FAIL IN THIS MANNER THE WIRE WOULD BE OVER BENT BY PUSHING OR PULLING OR OVER TORQUED BY TURNING AND WOULD REQUIRE THE TIP TO BE TRAPPED WITHIN THE ANATOMY OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE WIRE AS DESCRIBED. PATIENT ANATOMY, LESION MORPHOLOGY, AND/OR RESISTANCE BETWEEN THE PRODUCTS CAN ALL BE FACTORS. ANY ATTEMPTS TO MOVE THE WIRE IN A TRAPPED STATE COULD HAVE THEN CAUSED THE REPORTED TIP SEPARATION. IN THIS CASE, THE LESION WAS DESCRIBED AS MODERATELY CALCIFIED, TIGHT AND NARROW WHICH COULD HAVE CONTRIBUTED TO THE REPORTED INABILITY TO CROSS THE LESION AND DIFFICULTY RETRACTING THE GUIDE WIRE THAT LIKELY RESULTED REPORTED GUIDE WIRE TIP SEPARATION. INSTRUCTIONS FOR USE, DO NOT: PUSH, AUGER, WITHDRAW OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. TORQUE A GUIDE WIRE IF THE TIP BECOMES ENTRAPPED WITHIN THE VASCULATURE. ALLOW THE GUIDE WIRE TIP TO REMAIN IN A PROLAPSED CONDITION. 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. THE GUIDE WIRE WAS NOT RETURNED WHICH COULD HAVE AIDED IN THE EVALUATION. REPORTEDLY, AN ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED PORTION OF THE GUIDE WIRE WITH A SNARE DEVICE BUT WAS NOT SUCCESSFUL. THE SEPARATED PORTION WAS STENTED AGAINST THE WALL OF THE CIRCUMFLEX. THE PATIENT STILL EXPERIENCING SOMEWHAT ATYPICAL CHEST PAIN AND IS BEING FOLLOWED BY ANOTHER PHYSICIAN. THE CHEST PAIN IS POSSIBLE FROM RESIDUAL ISCHEMIA FROM THE PROCEDURE. 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. OVERALL, THE REPORTED GUIDE WIRE TIP SEPARATION, INABILITY TO CROSS THE LESION AND DIFFICULT TO REMOVE, ANGINA, ISCHEMIA, DISSECTION, DEVICE EMBEDDED IN VESSEL, ADDITIONAL THERAPY/NON-SURGICAL PROCEDURE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS ON (B)(6) 2010. THE PATIENT HAD A LESION IN THE LEFT POSTEROLATERAL (PL) BRANCHES AND THE PILOT GUIDE WIRE WAS USED TO TRY AND CROSS THE LESION. UNFORTUNATELY IT GOT STUCK (POSSIBLY FROM THE TIGHT NARROWING IT HAD CROSSED VS GOING SUBINTIMAL) AND COULD NOT BE PULLED BACK, AS IF THE COATING AT THE END WAS CAUGHT. THE GUIDE WIRE WAS GENTLY PULLED AND IT KEPT "UNRAVELLING" AND EVENTUALLY SEPARATED IN THE CIRCUMFLEX (CX) (FROM WHICH THE PLS WERE ARISING). SNARING OF THE GUIDE WIRE WAS ATTEMTPED WITHOUT SUCCESS. IN THE END, THE GUIDE WIRE WAS STENTED AGAINST THE VESSEL WALL OF THE CX. THE PATIENT STILL HAS SOMEWHAT ATYPICAL CHEST PAIN TO THIS DATE AND IS BEING FOLLOWED BY ANOTHER PHYSICIAN. THE CHEST PAIN IS POSSIBLY FROM RESIDUAL ISCHEMIA FROM THESE PLS, ALTHOUGH A TREADMILL TEST WAS APPARENTLY NORMAL ON DISCHARGE SO IT COULD ALSO HAVE ANOTHER ETIOLOGY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS ON (B)(6) 2010. THE PATIENT HAD A VERY TIGHT CALCIFIC LESION IN THE LEFT POSTEROLATERAL (PL) BRANCHES AND THE PILOT GUIDE WIRE WAS USED TO TRY AND CROSS THE LESION. UNFORTUNATELY IT GOT STUCK (POSSIBLY FROM THE TIGHT NARROWING IT HAD CROSSED VS GOING SUBINTIMAL) AND COULD NOT BE PULLED BACK, AS IF THE COATING AT THE END WAS CAUGHT. THE GUIDE WIRE WAS GENTLY PULLED AND IT KEPT "UNRAVELLING" AND EVENTUALLY SEPARATED IN THE CIRCUMFLEX (CX) (FROM WHICH THE PLS WERE ARISING). SNARING OF THE GUIDE WIRE WAS ATTEMPTED WITHOUT SUCCESS. THE VESSEL DISSECTED BACK TO THE LEVEL OF THE PROXIMAL CX AND WAS TREATED WITH 70MLS OF STENT. IN THE END, THE GUIDE WIRE WAS STENTED AGAINST THE VESSEL WALL OF THE CX. THE PATIENT RETURNED TO THE WARD AND WAS DISCHARGED (B)(6) 2010. THE PATIENT STILL HAS SOMEWHAT ATYPICAL CHEST PAIN TO THIS DATE AND IS BEING FOLLOWED BY ANOTHER PHYSICIAN. THE CHEST PAIN IS POSSIBLY FROM RESIDUAL ISCHEMIA FROM THESE PLS, ALTHOUGH A TREADMILL TEST WAS APPARENTLY NORMAL ON DISCHARGE SO IT COULD ALSO HAVE ANOTHER ETIOLOGY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention