BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE COMMAND 18 GUIDE WIRE

    MDR report key: 17820958 · Received September 26, 2023

    Report

    Report Number
    2024168-2023-10586
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    July 17, 2023
    Report Date
    October 25, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    PMA / PMN Number
    K152404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE POLYMER COATING SEPARATED FROM THE CORE AND FOLDED OVER ITSELF DISTAL TO THE PRETIN AREA OF THE CORE. UNABLE TO CONFIRM IF ALL PORTION OF POLYMER COATING REMAINED INTACT AND RETURNED. THE POLYMER COATING MATERIAL AT THE SEPARATION WAS STRETCHED AND TORN. 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 INCIDENTS/COMPLAINTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE NOTED MATERIAL SEPARATION (POLYMER) APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES. D4: LOT NUMBER UPDATED FROM UNKNOWN TO 3040461.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3: DATE OF EVENT ESTIMATED D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HT COMMAND 18 GUIDE WIRE MALFUNCTIONED DURING A VENOUS TRUNK REVASCULARIZATION. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DEVICE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. RETURNED DEVICE ANALYSIS IDENTIFIED THE POLYMER COATING ON THE HT COMMAND GUIDE WIRE SEPARATED FROM THE CORE AND FOLDED OVER ITSELF DISTAL TO THE PERTAIN AREA OF THE CORE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019755 HI-TORQUE COMMAND 18 GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR 3040461

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown