BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3230370 · Received July 16, 2013

    Report

    Report Number
    2024168-2013-04480
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 11, 2013
    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). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOSITY, MODERATELY CALCIFIED, DE NOVO, 90% STENOSIS IN THE MID LEFT CIRCUMFLEX CORONARY ARTERY (LCX). THE 2.0X15 MM RX MINI TREK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED AT FIRST INFLATION OF 10 ATMOSPHERES. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OR REMOVAL OF THE DEVICE. THERE WAS NO DAMAGE OF EFFECT TO THE VESSEL. AN NC TREK WAS USED AND DILATED THE LESION, BLOOD FLOW WAS IMPROVED AND THE PROCEDURE WAS FINISHED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327870 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21122G1

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: SION