BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3843645 · Received June 2, 2014

    Report

    Report Number
    2024168-2014-03520
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. DUE TO THE CONDITION OF THE CATHETER THE REPORTED DIFFICULT TO REMOVE WAS NOT CONFIRMED. BASED ON VISUAL, DIMENSIONAL AND FUNCTIONAL 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 SIMILAR INCIDENTS 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 THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, DE NOVO, 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY. REPORTEDLY, DURING POST-DILATATION, THE NC TREK WAS INFLATED AT 18 ATMOSPHERES FOR 10 SECONDS. WHEN ATTEMPTING TO REMOVE THE NC TREK FROM THE PATIENT ANATOMY, THE NC TREK COULD NOT BE PULLED INTO THE GUIDING CATHETER. THE BALLOON WAS INFLATED AND DEFLATED SEVERAL TIMES, BUT COULD NOT BE PULLED INTO THE GUIDING CATHETER TO BE REMOVED AS A SINGLE UNIT. THE PHYSICIAN PULLED THE NC TREK HARD AND IT WAS REMOVED FROM THE PATIENT ANATOMY. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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
    322268 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 31016G1

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: LAUNCHER 6FR AL 10