BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 15475887 · Received September 24, 2022

    Report

    Report Number
    2024168-2022-09974
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    September 1, 2022
    Report Date
    October 17, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ESTIMATED DATE OF EVENT. THE UDI NUMBER IS NOT KNOWN AS 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), CORRECTIVE ACTION TRACKING SYSTEM FOR THE WEB (CATSWEB) DATABASE REVIEW AND SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED SINCE THE PART/LOT NUMBERS WERE NOT REPORTED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULT TO ADVANCE, DIFFICULT TO REMOVE, OR PRODUCT QUALITY PROBLEM. 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.

    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 FOR THIS PRODUCT WERE NOT PERFORMED SINCE THE PART/LOT NUMBERS WERE NOT REPORTED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULT TO ADVANCE, DIFFICULT TO REMOVE, OR PRODUCT QUALITY PROBLEM. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.D1 - BRAND NAME UPDATED FROM HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE TO: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE. D4 - CATALOG NO UPDATED FROM UNKNOWN UNIVERSAL BMW TO: UNK UNIVERSAL BMW II H10 - ADDTL MFG NARRATIVE: REVISED BASED ON THE CATALOG NO UPDATE.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A GENERAL COMMENT REGARDING HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERAL II GUIDE WIRES THAT THERE ARE PROBLEMS WITH LUBRICITY AND HAVING FRICTION WITH OTHER DEVICES SUCH AS CATHETERS, STENT AND BALLOONS. THE HT BMW UNIVERSL II GUIDE WIRES WERE STILL REMOVED INDEPENDENTLY BUT IN SOME CASES THE WIRE COULD NOT COME OUT OF THE BALLOON CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435482 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown