BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 6996032 · Received November 2, 2017

    Report

    Report Number
    2024168-2017-08612
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 16, 2017
    Report Date
    November 2, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648151873
    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). INTERNAL FILE NUMBER - (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: DIL CATH: SAPPHIRE 2X10, HIRYU PLUS 3X10, GUIDE WIRE: RUN THROUGH, GUIDE CATH: HYPERION, STENT: SYNERGY 2.75X24. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, ECCENTRIC AND MILDLY CALCIFIED DE NOVO PROXIMAL AND MID LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. AN UNSPECIFIED GUIDE WIRE CROSSED THE LESION AND PRE-DILATATION WAS DONE WITH A 2.0 X 10 MM NON-ABBOTT DILATATION CATHETER. A 2.75 X 24 MM NON-ABBOTT STENT WAS THEN DEPLOYED. ADDITIONALLY, A 3.0 X 15 MM NC TREK WAS ADVANCED AND MET INITIAL RESISTANCE WITH THE ANATOMY. HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. THE DEVICE WAS THEREFORE REMOVED FROM THE ANATOMY AND THE RUPTURE WAS CONFIRMED. THE NC TREK DEVICE WAS THEN REPLACED WITH A NON-ABBOTT DILATATION CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776426 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 70611G1 08717648151873

    Patients

    Seq Age Sex Outcome Treatment
    1