BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3874978 · Received June 16, 2014

    Report

    Report Number
    2024168-2014-03861
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR DIFFICULT TO REMOVE GUIDE WIRE REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE NON-TORTUOUS, ECCENTRIC, MILDLY CALCIFIED, 75% STENOSED, MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A VESSEL DIAMETER OF 2.7 MM AND LESION LENGTH OF 10 MM, PREDILATATION WAS PERFORMED WITH A TREK BALLOON DILATATION CATHETER (BDC) AT 10 ATMOSPHERE (ATM). AFTER INFLATION IT WAS NOTED THAT THE BDC BECAME STUCK WITH THE GUIDE WIRE AND BOTH DEVICES WERE REMOVED AS A SYSTEM. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353382 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40211G1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR