BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    MDR report key: 5726791 · Received June 15, 2016

    Report

    Report Number
    2024168-2016-03909
    Event Type
    Injury
    Date Received
    June 15, 2016
    Date of Event
    May 17, 2016
    Report Date
    August 16, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED SEPARATION WAS CONFIRMED ALTHOUGH DIFFICULT TO REMOVE AND ENTRAPMENT OF THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES AND TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT CORONARY LESIONS LOCATED IN THREE VESSELS FROM THE COMMON TRUNK/AORTA/LEFT ANTERIOR DESCENDING (LAD), TO THE LEFT CIRCUMFLEX AND RAMUS. THREE GUIDE WIRES (GWS) WERE USED FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). STENTS WERE DEPLOYED IN THE LAD AND CIRCUMFLEX AND POST-DILATED USING KISSING BALLOON TECHNIQUE. DURING RETRIEVAL OF THE GWS, TWO OF THE GWS WERE REMOVED WITHOUT ANY ISSUES; HOWEVER, WHEN THE THIRD GW, THE BALANCE HYDRO, WAS BEING REMOVED, A LITTLE RESISTANCE WAS FELT AND ANGIOGRAPHY SHOWED PART OF THE WIRE HAD BROKEN AND REMAINED IN THE STENT DEPLOYED IN THE LAD. IT IS POSSIBLE THAT THE TIP OF THE GUIDE WIRE WAS JAILED BY THE DEPLOYED STENT. ATTEMPTS TO SNARE THE SEPARATED PIECE WERE UNSUCCESSFUL. THE PROCEDURE WAS ENDED AND THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO ATTEMPT TO REMOVE THE BROKEN GW; HOWEVER, THIS WAS ALSO UNSUCCESSFUL. ADDITIONALLY, DURING THIS INTERVENTION THE STENT WAS CONFIRMED TO BE PROPERLY POSITIONED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381026 HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT 5100771

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R