BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 18888078 · Received March 12, 2024

    Report

    Report Number
    2024168-2024-03218
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    February 5, 2024
    Report Date
    April 25, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    UDI-DI
    08717648118739
    PMA / PMN Number
    K072460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT UPDATED FROM 2/1/2024 TO 2/5/2024. B6: RELEVANT TEST/LABORATORY DATA UPDATED FROM 2/1/2024 TO 2/5/2024. D4: LOT NUMBER UPDATED FROM UNKNOWN TO 3030871. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED. THE REPORTED MATERIAL SEPARATION WAS CONFIRMED. THE REPORTED DIFFICULT TO REMOVE COULD NOT BE TESTED DUE TO THE DEVICE CONDITION. THE REPORTED DEVICE DAMAGED BY ANOTHER DEVICE COULD NOT BE TESTED AS IT WAS BASED ON OPERATIONAL CONTEXT. A REVIEW OF THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) DATABASE WAS PERFORMED AND REVEALED NO RELATED COMPLAINT ASSESSMENT CAPAS. THE ELECTRONIC LOT HISTORY RECORD (ELHR) IDENTIFIED NO ASSOCIATED MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO INDICATION OF A LOT SPECIFIC ISSUE. IT WAS REPORTED THAT A STENT WAS IMPLANTED IN A WAY, SUCH THAT, THE GUIDE WIRE BECAME JAILED. IT SHOULD BE NOTED THAT THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II INSTRUCTIONS FOR USE, STATES: ¿DO NOT: DEPLOY A STENT SUCH THAT IT WILL ENTRAP THE WIRE BETWEEN THE VESSEL WALL AND THE STENT.¿ IN THIS CASE, IT IS LIKELY THAT THE REPORTED ISSUES OF DIFFICULTY DURING REMOVAL, MATERIAL SEPARATION, AND GUIDE WIRE DAMAGE, WERE A RESULT OF THE GUIDE WIRE BEING JAILED AND SUBSEQUENT MANIPULATION USED TO REMOVE THE WIRE. ADDITIONALLY, IT WAS NOTED THAT THE SEPARATED GUIDE WIRE TIP REMAINS FREE FLOATING IN THE PATIENT¿S ANATOMY. IT WAS REPORTED THAT WHEN RESISTANCE WAS ENCOUNTERED, EXCESSIVE FORCE WAS APPLIED TO THE WIRE. IT SHOULD BE NOTED THAT THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II INSTRUCTIONS FOR USE, STATES: ¿DO NOT: PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE.¿ IN THIS CASE, IT WAS NOTED THAT THE GUIDE WIRE WAS JAILED; THEREFORE, THE DEVIATION APPEARS TO BE A REASONABLE CLINICAL RESPONSE TO THE DIFFICULTY. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES, PATIENT EFFECT, AND TREATMENT APPEAR TO BE RELATED TO USER ERROR. IT WAS REPORTED THAT A STENT WAS IMPLANTED IN A WAY, SUCH THAT, THE GUIDE WIRE BECAME JAILED. IT SHOULD BE NOTED THAT THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II INSTRUCTIONS FOR USE STATES: ¿DO NOT: DEPLOY A STENT SUCH THAT IT WILL ENTRAP THE WIRE BETWEEN THE VESSEL WALL AND THE STENT.¿ IN THIS CASE, IT IS LIKELY THAT THE REPORTED ISSUES OF DIFFICULTY DURING REMOVAL, MATERIAL SEPARATION, AND GUIDE WIRE DAMAGE, WERE A RESULT OF THE GUIDE WIRE BEING JAILED AND SUBSEQUENT MANIPULATION USED TO REMOVE THE WIRE. ADDITIONALLY, IT WAS NOTED THAT THE SEPARATED GUIDE WIRE TIP REMAINS FREE FLOATING IN THE PATIENT¿S ANATOMY. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT ESTIMATED D4: THE UDI IS UNKNOWN BECAUSE THE PART/LOT NUMBER WERE NOT PROVIDED. H6: MEDICAL DEVICE PROBLEM CODE 2017 - EXCESSIVE FORCE H6: MEDICAL DEVICE PROBLEM CODE 2017 - FAILURE TO FOLLOW STEPS / INSTRUCTIONS MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CALCIFIED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. DURING USE, THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. AN UNSPECIFIED STENT WAS IMPLANTED IN ANOTHER BRANCH AND JAILED THE GUIDE WIRE. THERE WAS RESISTANCE DURING REMOVAL AND FORCE WAS APPLIED. THE GUIDE WIRE TIP SEPARATED AND WAS ATTEMPTED TO BE REMOVED BY SNARE BUT WAS UNSUCCESSFUL. THE TIP REMAINS FREE FLOATING IN THE PATIENT. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721151 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR 3030871 08717648118739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention