BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4171284 · Received October 14, 2014

    Report

    Report Number
    2024168-2014-06690
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF A 3.25 X 15 MM NC TREK BALLOON CATHETER, THE PROTECTIVE SHEATH WAS DIFFICULT TO REMOVE. THE SHEATH WAS FINALLY REMOVED AND THE BALLOON CATHETER WAS SUCCESSFULLY USED TO POST-DILATE AN IMPLANTED DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    UPDATED DESCRIPTION: IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID LEFT ANTERIOR DESCENDING ARTERY. DURING PREPARATION OF A 3.25 X 15 MM NC TREK BALLOON CATHETER, THE PROTECTIVE SHEATH WAS DIFFICULT TO REMOVE. THE SHEATH WAS FINALLY REMOVED AND THE BALLOON CATHETER WAS SUCCESSFULLY USED TO POST-DILATE AN IMPLANTED DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651499 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40422G1

    Patients

    Seq Age Sex Outcome Treatment
    1