BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3150647 · Received June 6, 2013

    Report

    Report Number
    2024168-2013-03535
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    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 ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE NON-TORTUOUS, NON-CALCIFIED, PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, FOR TREATMENT OF A 90% DE NOVO LESION, PRE-DILATATION WAS PERFORMED SUCCESSFULLY USING A 2.0X15 TREK BALLOON. A 3.0X23 XIENCE PRIME STENT WAS IMPLANTED. A 3.0X12 NC TREK RX BALLOON WAS USED TO PERFORM POST DILATATION. DURING THE FIRST INFLATION THE BALLOON WAS INFLATED TO 10 ATMOSPHERES. DURING THE SECOND INFLATION, THE BALLOON DID NOT INFLATE. BLOOD BACK FLOW WAS OBSERVED WHEN NEGATIVE PRESSURE WAS APPLIED AND THE PHYSICIAN ASSUMED THAT BALLOON RUPTURE HAD OCCURRED. THE DEVICE WAS WITHDRAWN FROM THE ANATOMY AND A NEW NC TREK 3.0X15 BALLOON WAS USED TO COMPLETE POST DILATATION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251034 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30127G2

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: XIENCE PRIME 3.0 X 23 MM