BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HT TURNTRAC

    MDR report key: 10352899 · Received July 31, 2020

    Report

    Report Number
    2024168-2020-06390
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    July 19, 2020
    Report Date
    July 31, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    PMA / PMN Number
    K173795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: ESTIMATED DATE OF EVENT. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD (ELHR) AND SIMILAR INCIDENT QUERY FOR THIS PRODUCT WERE NOT PERFORMED SINCE THE PART AND LOT NUMBERS WERE NOT REPORTED. THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTY TO ADVANCE AND REMOVE THE GUIDE WIRE APPEAR TO BE RELATED TO OPERATIONAL CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL HT TURN TRAC REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING LESION. TWO HI-TURNTRAC GUIDE WIRES (GW) WERE USED AND NOTED THAT THERE WAS FRICTION BETWEEN THE DEVICES. THE TURNTRAC GUIDE WIRES WERE ATTEMPTED TO BE REMOVED SINGULARLY BUT UNABLE TO DUE TO RESISTANCE WITH EACH OTHER. THEREFORE, BOTH GWS WERE REMOVED TOGETHER. PER THE PHYSICIAN, THERE WAS NO VISIBLE DAMAGE TO THE WIRES. THERE WERE NO PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813804 HT TURNTRAC GUIDE WIRE DQX ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1