BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 17671309 · Received September 1, 2023

    Report

    Report Number
    2024168-2023-09565
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    June 18, 2023
    Report Date
    November 15, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    UDI-DI
    08717648014345
    PMA / PMN Number
    K101011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED. ATTACHMENT MEDWATCH REPORT #MW5119967NA.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED 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. A QUERY OF THE COMPLAINT HANDLING SYSTEM FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO OTHER INCIDENTS/COMPLAINTS. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENTS APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. B5 - DESCRIBE EVENT OR PROBLEM: UPDATED. D4: LOT NUMBER UPDATED FROM UNKNOWN TO 2040871. E1 - INITIAL REPORTER UPDATED.

    Description of Event or Problem · 0

    RECEIVED MEDWATCH MW5119967 WHICH STATES: WE THEN TRIED PULL BACK THE BMW WIRE BUT THE WIRE RADIO-OPAQUE SEGMENT/TIP BECAME WEDGED BEHIND THE STRUTS OF THE STENT THAT WE HAD JUST DEPLOYED. HOWEVER AS WE PULLED THE WIRE THROUGH THE CATHETER, THE TIP OF THE WIRE BROKE LOOSE BEHIND THE STENT BUT DID NOT EMBOLIZE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL REPORTED INFORMATION, IT WAS REPORTED THAT THE PATIENT PRESENTED ST ELEVATION MYOCARDIAL INFARCTION (STEMI) AND THE PROCEDURE WAS TO TREAT AN 80% ECCENTRIC FOCAL DISEASE OF THE MID LEFT CIRCUMFLEX CORONARY ARTERY AT THE BIFURCATION. THE BMW GUIDE WIRE WAS ABLE TO BE MANEUVERED INTO THE DISTAL LEFT CIRCUMFLEX ACROSS THE MID CIRCUMFLEX LESION. THE GUIDE WIRE WAS RETRIEVED VIA SNARE AND A REMAINING PORTION WAS FIXED TO THE VESSEL WALL WITH A 2.75X22 MM STENT. THE PROCEDURE WAS EXTENDED DUE TO THIS PORTION OF THE PROCEDURE AND THE PATIENT WITH PERSISTENT HYPOTENSION ETIOLOGY WAS UNCLEAR. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603014 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR 2040871 08717648014345

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Hospitalization| R| O