BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4090484 · Received September 15, 2014

    Report

    Report Number
    2024168-2014-05928
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULT TO REMOVE THE PROTECTIVE SHEATH WAS NOT CONFIRMED DUE TO THE PROTECTIVE SHEATH NOT BEING RETURNED. THE REPORTED UNUSUAL APPEARANCE WAS NOT CONFIRMED, BUT MAY HAVE BEEN DUE TO THE FORCE APPLIED DURING DIFFICULTY REMOVING THE PROTECTIVE SHEATH. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR UNUSUAL APPEARANCE OR DIFFICULT TO REMOVE THE PROTECTIVE SHEATH REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, WHEN THE CHIPBOARD BOX WAS OPENED FOR A 3.5X15 MM NC TREK DILATATION CATHETER THE YELLOW PROTECTIVE SHEATH WAS STUCK TO THE BALLOON AND COULD NOT BE REMOVED. FORCE WAS APPLIED TO REMOVE THE PROTECTIVE SHEATH; HOWEVER, THE BALLOON WAS DAMAGED (SHAPE OF THE BALLOON). THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW SAME SIZED NC TREK DILATATION CATHETER WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570279 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40512G1

    Patients

    Seq Age Sex Outcome Treatment
    1