BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PILOT GUIDE WIRE

    MDR report key: 1912346 · Received November 11, 2010

    Report

    Report Number
    2024168-2010-02420
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    August 2, 2010
    Report Date
    October 22, 2010
    Manufacturer
    AV-MURRIETA
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). FOR THE GUIDE WIRE TO FAIL IN THIS MANNER, THE GUIDE 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 GUIDE 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 ECCENTRIC WHICH COULD HAVE CONTRIBUTED TO THE GUIDE WIRE BEING TRAPPED AND RESULTING IN THE REPORTED GUIDE WIRE SEPARATION. IT WAS REPORTED THAT THE GUIDE WIRE WAS PROBABLY TRAPPED BENEATH THE STENT STRUTS AND RESULTED IN THE REPORTED PROLAPSED TIP. PER INSTRUCTIONS FOR USE (IFU), CONSIDER THAT IF A SECONDARY GUIDE WIRE IS PLACED IN A BIFURCATION BRANCH, THIS GUIDE WIRE MAY NEED TO BE RETRACTED PRIOR TO STENT DEPLOYMENT BECAUSE THERE IS ADDITIONAL RISK THAT THE SECONDARY GUIDE WIRE MAY BECOME ENTRAPPED BETWEEN THE VESSEL WALL AND THE STENT. OVERALL, THE REPORTED GUIDE WIRE TIP SEPARATION, PROLAPSED TIP, OCCLUSION, REMOVAL OF FOREIGN BODY, SURGICAL PROCEDURE, ADDITIONAL THERAPY/NON-SURGICAL TREATMENT, AND HOSPITALIZATION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A USER MEDWATCH THAT THE PILOT GUIDE WIRE SEPARATED INSIDE THE PATIENT RESULTING IN AN OCCLUSION AND SURGICAL INTERVENTION. THE PROCEDURE WAS TO TREAT AN IN-STENT RESTENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA). THE POSTERIOR DESCENDING ARTERY (PDA) WAS DIFFUSELY DISEASED. AFTER SUCCESSFUL RE-STENTING OF PRCA WITH DRUG ELUTING STENTS THE PATIENT DEVELOPED ST ELEVATIONS INFERIORLY WITH SLUGGISH FLOW IN THE PDA. A BALLOON WAS DILATED IN THE PDA WITHOUT IMPROVEMENT IN ECG OR SYMPTOMS. ATTEMPTS AT PASSING A DRUG ELUTING STENT ACROSS THE PDA STENOSIS WERE UNSUCCESSFUL DESPITE USE OF TWO PILOT 50S AS BUDDY WIRES. ULTIMATELY A 2.5MM BARE METAL STENT CROSSED AND WAS DEPLOYED. THE PILOT GUIDE WIRE IN PLACE AT TIME OF INFLATION WAS PROLAPSED AND PROBABLY TRAPPED BENEATH THE STENT STRUTS. ATTEMPTS AT REMOVAL WERE UNSUCCESSFUL WITH ULTIMATE GUIDE WIRE FRACTURE AND ACUTE CLOSURE OF THE RCA. THE PATIENT WAS SENT TO THE OPERATING ROOM AND AFTER INTRA-AORTIC BALLOON PUMP WAS IN STABLE CONDITION WITH SUCCESSFUL SURGICAL REVASCULARIZATION PROCEDURE. HEALTH PROFESSIONAL'S IMPRESSION - THE GUIDE WIRE BROKE FOLLOWING DEPLOYMENT OF THE STENT WHEN THE CLINICIAN BELIEVED THE GUIDE WIRE TO BE IN THE BRANCH OF THE ARTERY RATHER THAN LOOPED (PROLAPSED). THIS REQUIRED OPEN HEART PROCEDURE TO RETRIEVE THE SEPARATED PORTION OF GUIDE WIRE AND REVASCULARIZE. 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-MURRIETA NA 0052791

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R