BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC

    MDR report key: 1241723 · Received November 20, 2008

    Report

    Report Number
    2024168-2008-01194
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    May 15, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. THE IFU WARNS TO: "CONSIDER THAT IF A SECONDARY WIRE IS PLACED IN A BIFURCATION BRANCH, THIS WIRE MAY NEED TO BE RETRACTED PRIOR TO STENT DEPLOYMENT BECAUSE THERE IS ADDITIONAL RISK THAT THE SECONDARY WIRE MAY BECOME ENTRAPPED BETWEEN THE VESSEL WALL AND THE STENT." THE RESULTING PATIENT EFFECTS ARE MOST LIKELY THE RESULT OF CASE CIRCUMSTANCES AND NOT A MANUFACTURING RELATED ISSUE, THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SEROUS INJURY - MEDICAL INTERVENTION/PERMANENT IMPAIRMENT. REPORTING RATIONALE: SEPARATED GUIDE WIRE TIP EMBEDDED IN VESSEL RESULTING IN OCCLUSION AND MI. DEVICE ISSUES: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PATIENT EXPERIENCING CRESCENDO ANGINA. TWO BALANCE GUIDE WIRES WERE BEING USED IN THE PROCEDURE. FOLLOWING STENT IMPLANTATION ONE OF THE GUIDE WIRES BECAME JAILED BY THE STENT AND WHEN ATTEMPTING TO REMOVE IT, THE TIP UNRAVELED AND BECAME SEPARATED. A STENT WAS USED TO EMBED THE TIP AGAINST THE VESSEL WALL. BY THE END OF THE PROCEDURE, THE ARTERY DISTAL TO THE STENT WAS OCCLUDED BY THROMBUS, WHICH COULD NOT BE REMOVED, RESULTING IN CHEST PAIN AND A SMALL MYOCARDIAL INFARCTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8031681

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention| S