BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3163400 · Received June 11, 2013

    Report

    Report Number
    2024168-2013-03656
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 25, 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). CONCOMITANT PRODUCTS: GUIDE WIRE: SION; GUIDE CATH: HEARTRAIL 6F AL1. 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-CONFORMANCE 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 LESION LOCATED IN THE MODERATELY TORTUOUS, HEAVILY CALCIFIED, 90% STENOSED, MID RIGHT CORONARY ARTERY. THE 3.5X15 MM TREK BALLOON CATHETER WAS DELIVERED FOR PRE-DILATATION WITHOUT RESISTANCE; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION AT 6 ATMOSPHERES. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT WITHOUT ANY RESISTANCE FELT. THERE WAS NO SAME SIZED BALLOON, SO A DIFFERENT SIZED TREK WAS DELIVERED AND SUCCESSFULLY INFLATED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264181 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21011G1

    Patients

    Seq Age Sex Outcome Treatment
    1