BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT

    MDR report key: 18144744 · Received November 15, 2023

    Report

    Report Number
    2024168-2023-12735
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 1, 2023
    Report Date
    June 24, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    DQX
    PMA / PMN Number
    K152709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 WERE NOT PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULT TO ADVANCE/REMOVE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE ADDITIONAL GUIDE WIRES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    H2 CORRECTION: UPDATED THE DEVICE IDENTIFICATION FIELDS TO ALIGN WITH THE INFORMATION IN THE CORRESPONDING FIELDS IN GUDID. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, 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 WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULT TO ADVANCE/REMOVE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A GENERAL COMMENT THAT DURING PROCEDURES OF GREATER COMPLEXITY, THE BALANCE MIDDLEWEIGHT (BMW), BMW UNIVERSAL II, BALANCE HEAVYWEIGHT, WHISPER MS AND WHISPER EXTRA SUPPORT GUIDE WIRES LOSE THEIR HYDROPHILICITY. THERE IS RESISTANCE WITH BALLOONS, STENTS AND IMAGING CATHETERS AND THE GUIDE WIRES ARE SIMPLY REMOVED WITH THE OTHER DEVICE AS A SINGLE UNIT BECAUSE THE DEVICES ARE STUCK TO EACH OTHER. THERE WERE NO ADVERSE PATIENT EFFECTS AND THE LENGTH OF THE PROCEDURE IS EXTENDED AND THERE IS GREATER EXPOSURE TO X RAYS BUT THERE IS NO CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243244 HI-TORQUE BALANCE MIDDLEWEIGHT WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR INC. 1001780J-HC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown