BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    MDR report key: 4103076 · Received September 19, 2014

    Report

    Report Number
    2024168-2014-06065
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS CONFIRMED. THE DIFFICULT TO REMOVE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. 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 A LESION IN THE MILDLY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER DEPLOYMENT OF AN UNSPECIFIED STENT IMPLANT, THE BALANCED MIDDLE WEIGHT (BMW) GUIDE WIRE WAS RE-CROSSED THROUGH THE SIDE STRUTS OF THE DEPLOYED STENT IMPLANT AT A BIFURCATION. DURING WITHDRAWAL OF THE BMW GUIDE WIRE, SLIGHT RESISTANCE WAS MET, SLIGHT FORCE WAS APPLIED, AND THE TIP OF THE GUIDE WIRE SEPARATED. THE PROXIMAL END OF THE BMW GUIDE WIRE WAS PULLED INTO THE GUIDING CATHETER AND SUCCESSFULLY REMOVED TOGETHER AS A SINGLE UNIT. NO ATTEMPTS WERE MADE TO SNARE THE SEPARATED TIP OF THE BMW GUIDE WIRE. AN UNSPECIFIED STENT IMPLANT WAS DEPLOYED TO TREAT THE BIFURCATION AND EMBED THE SEPARATED BMW GUIDE WIRE TIP. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582647 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT 4052371

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention