BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 8206280 · Received December 31, 2018

    Report

    Report Number
    2024168-2018-10090
    Event Type
    Injury
    Date Received
    December 31, 2018
    Date of Event
    December 10, 2018
    Report Date
    July 31, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER - (B)(4). CORRECTION: LOT NUMBER UPDATED FROM 8072117 TO 8072171. THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, 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 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 SEPARATION AND DIFFICULTY TO REMOVE APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE EXTERNAL CAROTID ARTERY THAT DID NOT HAVE ANY CALCIFICATION. THE LESION WAS BEING DILATED AND A 3 CM BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS USED AND DID NOT MEET ANY RESISTANCE DURING THE PROCEDURE. HOWEVER, THE DEVICE MET RESISTANCE WITH THE ANATOMY DURING REMOVAL, AND THE TIP OF THE GUIDE WIRE SEPARATED INTO 2 PARTS INSIDE THE ANATOMY. THEREFORE, A CUT-DOWN PROCEDURE WAS PERFORMED TO REMOVE THE SEPARATED PORTIONS FROM THE LEFT CAROTID ARTERY AND THE DESCENDING AORTA. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046060 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 8072171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention