BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE II GUIDE WIRE

    MDR report key: 13044557 · Received December 20, 2021

    Report

    Report Number
    2024168-2021-11899
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    November 11, 2021
    Report Date
    February 4, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL AND DIMENSIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED GUIDE WIRE AND THE REPORTED BREAK/SEPARATION WAS CONFIRMED. THE REPORTED DIFFICULTY TO REMOVE WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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 SIMILAR INCIDENTS 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 TIP SEPARATION APPEARS TO BE RELATED TO CASE CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE REPORTED INFORMATION, IT IS LIKELY THAT MANIPULATION DURING THE PROCEDURE CAUSED THE TIP OF THE GUIDE WIRE TO GET CAUGHT ON THE IMPLANTED STENT RESULTING IN THE DIFFICULTY TO REMOVE. FURTHER MANIPULATION DURING RETRACTION LIKELY RESULTED IN THE TIP/SHAPING RIBBON BREAK/SEPARATION AND STRETCHED COILS. ADDITIONALLY, IT IS SUSPECTED THAT PART OF THE GW TIP BROKE OFF AND REMAINS IN THE ANATOMY BUT COULD NOT BE CONFIRMED. RETURNED ANALYSIS WAS UNABLE TO CONFIRM ANY MISSING PORTION OF THE GUIDE WIRE. CORROSION WAS NOTED ON THE GUIDE WIRE, AND LIKELY A RESULT OF EXPOSURE TO THE ELEMENTS DURING TRANSIT BACK TO ABBOTT VASCULAR FOR ANALYSIS RESULTING IN THE TIP SOLDER TO CORRODE THIS WAY. THE NOTED BEND ON THE GUIDE WIRE LIKELY OCCURRED DURING PACKING FOR RETURN ANALYSIS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY THAT WAS 90% STENOSED. A HI-TORQUE BALANCE MIDDLEWEIGHT (BMW) ELITE LL GUIDE WIRE (GW) WAS ADVANCED TO THE FIRST DIAGONAL ARTERY WHILE A SION GW WAS ADVANCED TO THE LAD. A 3.0 X22MM NON-ABBOTT STENT WAS THEN DEPLOYED AT THE LAD. DURING REMOVAL OF THE BMW GW IT BECAME STUCK WITH THE PREVIOUSLY DEPLOYED NON-ABBOTT STENT BUT ULTIMATELY ABLE TO BE REMOVED. IT IS SUSPECTED THAT PART OF THE GW TIP BROKE OFF AND REMAINS IN THE ANATOMY, BUT COULD NOT BE CONFIRMED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944140 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE II GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR 1032361

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other HYPERION JL4| RESOLUTE STENT 3.0×22MM| SION GW