BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE COMMAND 18 GUIDE WIRE

    MDR report key: 7803277 · Received August 21, 2018

    Report

    Report Number
    2024168-2018-06457
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    July 12, 2018
    Report Date
    August 22, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K152404
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED KINK WAS UNABLE TO BE CONFIRMED, HOWEVER THERE WAS NOTED MULTIPLE COATING DAMAGES. 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 INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED/NOTED DIFFICULTIES 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

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DATE ON THE INITIAL/30 DAY MDR WAS FILED AS 07/12/2018; HOWEVER, THE CORRECT DATE FOR THE INITIAL/30 DAY MDR IS 07/30/2018. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE TIBIAL ARTERY. AN 18 HT COMMAND GUIDE WIRE AND AN UNSPECIFIED BALLOON CATHETER WERE ADVANCED AND SUCCESSFULLY USED. AFTER THE GUIDE WIRE WAS REMOVED FROM THE BALLOON CATHETER, THE DISTAL END OF THE GUIDE WIRE BECAME DEFORMED [KINKED]. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. QAT ANALYSIS CONFIRMED THE POLYMER COATING SEPARATED AND THERE WAS NO KINKED TIP NOTED WITH THE GUIDE WIRE. BASED ON QAT FINDINGS THERE IS A POSSIBILITY THAT POLYMER COATING WAS LEFT INSIDE THE PATIENT WHICH IS CONSIDERED A PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642436 HI-TORQUE COMMAND 18 GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 8032661

    Patients

    Seq Age Sex Outcome Treatment
    1 Other