BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 12202663 · Received July 21, 2021

    Report

    Report Number
    2024168-2021-06280
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 14, 2021
    Report Date
    October 19, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    UDI-DI
    08717648014338
    PMA / PMN Number
    K101011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TWO STERILE/UNUSED HI-TORQUE BALNCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRES, PART# 1009660 AND LOT# 1032571, WERE RETURNED AND A VISUAL INSPECTION WAS PERFORMED ON THE GUIDE WIRE. NO DAMAGES OR STRETCHED COILS WERE NOTED. H6: TYPE OF INVESTIGATION CODE 4101 ADDED. H10: SUBSEQUENT TO FILING THE FINAL REPORT, IT WAS NOTED THAT THE ADDITIONAL INFORMATION REGARDING THE RETURN OF STERILE DEVICES HAD BEEN INADVERTENTLY LEFT OFF THE REPORT.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. 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 AND/OR COMPLAINTS REPORTED FROM THIS LOT. THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTY TO REMOVE AND STRETCHED COILS APPEAR TO BE RELATED TO OPERATIONAL CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE REPORTED INFORMATION, THE DIFFICULTY TO REMOVE WAS CAUSED BY THE HEAVILY CALCIFIED 75% STENOSED ANATOMY. IT IS LIKELY THAT DURING THE PROCEDURE, THE TIP OF THE GUIDE WIRE BECAME CAUGHT IN THE ANATOMY RESULTING IN THE DIFFICULT TO REMOVE. THE COILS LIKELY STRETCHED DUE TO MANIPULATION AGAINST RESISTANCE DURING RETRACTION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD) THAT IS 75% STENOSED. WHEN ATTEMPTING TO PULL BACK THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL (BMW) GUIDE WIRE RESISTANCE WAS MET WITH ANATOMY. THE ENTIRE GUIDE WIRE WAS REMOVED IN ONCE PIECE; HOWEVER, THE COILS WERE NOTED TO BE STRETCHED AND THE TIP WAS FLOPPY. ANOTHER NEW BMW WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099523 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR 1009660 1032571 08717648014338

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR