BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3203491 · Received July 2, 2013

    Report

    Report Number
    2024168-2013-04161
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE PART AND LOT NUMBERS WERE NOT REPORTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. EVENT, IMPLANT, AND THERAPY DATES: ESTIMATED DATE (REPORTED AS OCCURRING TWO WEEKS PRIOR TO ALERT DATE ON (B)(6) 2013).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TREK OTW BALLOON DILATATION CATHETER WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE MANUAL AND ADVANCED TO THE LESION. THE BALLOON WAS INFLATED TO 14 ATMOSPHERES WITH AN INDEFLATOR 30/30 INFLATION DEVICE AND THERE WAS AIR NOTED IN THE DISTAL END OF EACH OF THE BALLOONS. THE DEVICE WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302300 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION: INDEFLATOR 30/30 INFLATION DEVICE