BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE

    MDR report key: 15272270 · Received August 22, 2022

    Report

    Report Number
    2024168-2022-09041
    Event Type
    Malfunction
    Date Received
    August 22, 2022
    Date of Event
    July 28, 2022
    Report Date
    August 22, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    UDI-DI
    08717648222641
    PMA / PMN Number
    K173795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE OTHER TURNTRAC FLEX GUIDEWIRE (LOT#1101861) IS FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. THE 014 HT TURNTRAC FLEX GUIDEWIRE (GW) (LOT#1101861) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, AFTER SEVERAL ATTEMPTS THE GW FAILED TO CROSS DUE TO THE ANATOMY AND THE TIP OF THE GW BROKE. THE GW WAS REMOVED WITH DIFFICULTY DUE TO ANATOMY. THE GW REPLACED WITH ANOTHER SAME SIZE TURNTRAC GW (LOT#1102161). THE SECOND GW ALSO FAILED TO CROSS DUE TO THE ANATOMY AND THE THE TIP OF THE SECOND GW ALSO BROKE. THE SECOND GW WAS ALSO REMOVED WITH DIFFICULTY DUE TO THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT GW WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451132 0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR 1020010 1102161 08717648222641

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male