BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT¿ HYDROPHILIC COATIN

    MDR report key: 12715274 · Received October 28, 2021

    Report

    Report Number
    2024168-2021-09708
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    October 1, 2011
    Report Date
    October 28, 2021
    Product Code
    DQX
    PMA / PMN Number
    K021228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD (ELHR), CORRECTIVE ACTION TRACKING SYSTEM FOR THE WEB (CATSWEB) DATABASE REVIEW AND SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED SINCE THE PART AND LOT NUMBERS WERE NOT REPORTED AND THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE REPORT INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE OTHER ADVERSE PATIENT EFFECTS NOTED IN THE REPORT ARE FILED UNDER DIFFERENT MFR REPORT NUMBERS. POST-MARKET CLINICAL FOLLOW-UP EVALUATION REPORT CORONARY DILATATION CATHETERS.

    Description of Event or Problem · 1

    TITLE: POST MARKET CLINICAL FOLLOW-UP EVALUATION REPORT NITINOL, POLYMER, AND STAINLESS STEEL GUIDE WIRES. IT WAS REPORTED THAT THE POST MARKET CLINICAL FOLLOW-UP EVALUATION WAS PERFORMED TO COLLECT AND EVALUATE CLINICAL DATA IN REAL-WORLD CLINICAL SETTINGS TO CONFIRM SAFETY AND PERFORMANCE ON THE USE OF THE FOLLOWING GUIDE WIRES: HT ADVANCE/ADVANCE LITE, HT BALANCE, HT BALANCE HEAVY WEIGHT (BHW), HT BALANCE MIDDLE WEIGHT (BMW), HT BMW ELITE/ELITE II, HT BMW UNIVERSAL, HT BMW UNIVERSAL II, HT CROSS-IT XT, HT PILOT, HT PROGRESS, HT VERSATURN, AND HT WHISPER. THE PROCEDURES WERE PERFORMED BETWEEN (B)(6) 2011 THROUGH (B)(6) 2020. FOR THE HT BALANCE HEAVY WEIGHT (BHW), THE ADVERSE PATIENT EFFECTS INCLUDE DISSECTION AND THE DEVICE ISSUES INCLUDE FAILURE TO CROSS. DETAILS ARE LISTED IN THE POST-MARKET CLINICAL FOLLOW-UP EVALUATION REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612838 ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT¿ HYDROPHILIC COATIN GUIDE WIRE DQX

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other