BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE GUIDE WIRE WITH MICROGLIDE COATING

    MDR report key: 3081166 · Received April 26, 2013

    Report

    Report Number
    2024168-2013-02617
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED. THE FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL INSPECTION AND THE SCANNING ELECTRON MICROSCOPY IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS NOT COMPLETE. 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 A CHRONIC TOTALLY OCCLUDED MID RIGHT CORONARY ARTERY. A BALANCE GUIDE WIRE WAS BEING ADVANCED TO THE LESION WITH THE SUPPORT OF A NON-ABBOTT 1.5 X 15 MM BALLOON CATHETER; HOWEVER, THE GUIDE WIRE COULD NOT CROSS THE LESION. WHEN THE WIRE WAS BEING REMOVED WITH NO RESISTANCE FELT, THE DISTAL PORTION SEPARATED IN THE ANATOMY. ANOTHER GUIDE WIRE WITH THE SUPPORT OF A DIFFERENT BALLOON CATHETER WAS ADVANCED, TRAPPING THE SEPARATED PORTION OF THE GUIDE WIRE AND THE DEVICES WERE REMOVED AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED BY IMPLANTING A NON-ABBOTT STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181466 HI-TORQUE BALANCE GUIDE WIRE WITH MICROGLIDE COATING GUIDE WIRE DQX AV-TEMECULA-CT 2101171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIL CATH: 1.5 X 15 MM APEX