BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 15509549 · Received September 30, 2022

    Report

    Report Number
    2024168-2022-10143
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    September 1, 2022
    Report Date
    January 12, 2023
    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

    THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND SIMILAR INCIDENT REVIEW OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. 205 STERILE/UNUSED GUIDE WIRES WERE RETURNED. ON THE CHIPBOARD BOX AND FOIL POUCH LABEL: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II WITHOUT MARKER, 0.014" 190CM REF 1009666J, LOT 2031571. THERE WAS NO DAMAGE NOTED TO THE STERILE DEVICES. TESTS WERE SUCCESSFULLY PERFORMED ON A RANDOM SAMPLE OF 29 OF THE STERILE DEVICES WITH NO ANOMALIES NOTED. THERE WAS HYDROPHILIC COATING PRESENT THROUGHOUT THE SURFACE OF THE DISTAL END OF THE GUIDE WIRE, AS CONFIRMED VIA TACTILE INSPECTION WITH WATER. REPORTEDLY, WHEN THE GUIDE WIRE IS INSIDE THE PATIENT FOR A PERIOD LONGER THAN 40 MINUTES (MIN), THE GUIDE WIRE USUALLY STICKS INSIDE THE OTHER DEVICES, SUCH AS BALLOON, STENT AND CATHETERS, AND WHEN THIS INTERCURRENCE HAPPENS, THEY NEED TO REMOVE THE GUIDE WIRE ALONG WITH THE DEVICES. REPORTEDLY, CASES OF THIS OCCURRING ARE MORE FREQUENT WHEN THE PROCEDURES TAKE MORE THAN 40 MIN. IN THESE CASES, IT IS POSSIBLE THAT OVER A PERIOD OF TIME THE LUBRICITY OF THE GUIDE WIRE IS COMPROMISED DUE TO COAGULATION OF BLOOD AND/OR CONTRAST ON THE GUIDE WIRE; THUS RESULTING IN THE REPORTED DIFFICULTY TO ADVANCE AND REMOVE DEVICES OVER THE GUIDE WIRE; HOWEVER THIS CANNOT BE CONFIRMED. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 0

    ESTIMATED DATE OF EVENT THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND SIMILAR INCIDENT REVIEW OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WAS NOT PROVIDED. REPORTEDLY, WHEN THE GUIDEWIRE IS INSIDE THE PATIENT FOR A PERIOD LONGER THAN 40MIN, THE GUIDE WIRE USUALLY STICKS INSIDE THE OTHER DEVICES, SUCH AS BALLOON, STENT AND CATHETERS, AND WHEN THIS OCCURRENCE HAPPENS, THEY NEED TO REMOVE THE GUIDE WIRE ALONG WITH THE DEVICES. REPORTEDLY, CASES OF THIS OCCURRING ARE MORE FREQUENT WHEN THE PROCEDURES TAKE MORE THAN 40MIN. IN THESE CASES, IT IS POSSIBLE THAT OVER A PERIOD OF TIME THE LUBRICITY OF THE GUIDE WIRE IS COMPROMISED DUE TO COAGULATION OF BLOOD AND/OR CONTRAST ON THE GUIDE WIRE; THUS RESULTING IN THE REPORTED DIFFICULTY TO ADVANCE AND REMOVE DEVICES OVER THE GUIDE WIRE; HOWEVER THIS CANNOT BE CONFIRMED. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    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 UNIVERSAL II GUIDE WIRES WERE STILL REMOVED INDEPENDENTLY BUT IN SOME CASES THE DEVICES HAD TO BE REMOVED TOGETHER. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616936 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown