BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT VERSATURN GUIDE WIRE

    MDR report key: 14292371 · Received May 5, 2022

    Report

    Report Number
    2024168-2022-04878
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 20, 2022
    Report Date
    August 26, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    UDI-DI
    08717648198434
    PMA / PMN Number
    K141782
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED PEELED / DELAMINATED WAS UNABLE TO BE CONFIRMED. THE REPORTED FAILURE TO ADVANCE AND THE REPORTED PRODUCT QUALITY PROBLEM-NOISE WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS THEY WERE 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 IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. TWO UNOPENED STERILE VERSATURN GUIDE WIRES WERE RETURNED. PART NUMBER: 1013317 LOT NUMBER: 1100471. THE TWO STERILE/UNUSED DEVICES WERE VISUALLY INSPECTED AND THERE WAS NO DAMAGE NOTED TO ALL THE STERILE/UNUSED DEVICES. THERE WAS NO PEELING ON BOTH RETURNED GUIDE WIRES. THE CORE OUTER DIAMETERS WERE MEASURED WHICH MET SPECIFICATION. A 0.0145 INCH HOLE GAUGE WAS USED TO MEASURE THE SOLDER JOINTS OF THE RETURNED STERILE GUIDE WIRES WITH NO RESISTANCE NOTED, MEETING SPECIFICATION. IT IS POSSIBLE THAT DURING ADVANCEMENT THE GUIDE WIRE AND THE GUIDING CATHETER WERE NOT COAXIALLY ALIGNED (GUIDE WIRE WAS NOT INSERTED STRAIGHT) RESULTING IN INTERACTION WITH THE GUIDING CATHETER CAUSING RESISTANCE; THUS RESULTING IN THE REPORTED PRODUCT QUALITY PROBLEM ¿ NOISE AND THE REPORTED FAILURE TO ADVANCE; HOWEVER THIS CANNOT BE CONFIRMED. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED PRODUCT QUALITY PROBLEM ¿ NOISE AND THE REPORTED FAILURE TO ADVANCE CANNOT BE DETERMINED. THE REPORTED PEELED / DELAMINATED WAS NOT CONFIRMED. MANIPULATION OF THE DEVICE LIKELY RESULTED IN THE NOTED BENT CORE AND THE NOTED OFFSET TIP COILS. THE NOTED SCRAPPED TEFLON COATING LIKELY OCCURRED DUE TO INTERACTION WITH THE TORQUE DEVICE BEING TIGHT AGAINST THE GUIDEWIRE AND POSSIBLY CONTRIBUTED TO THE REPORTED PRODUCT QUALITY PROBLEM ¿ NOISE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED RIGHT CORONARY ARTERY. WHILE ADVANCING THE VERSATURN GUIDE WIRE (GW), THE DEVICE FAILED TO CROSS DUE TO ANATOMY WHEN AN UNKNOWN NOISE (AS IF IRON WAS BEING SCRATCHED FROM THE GW) WAS HEARD. THE GW WAS REMOVED AND REPLACED WITH ANOTHER DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764093 HT VERSATURN GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR 1013317 1100471 08717648198434

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown