BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 8558086 · Received April 26, 2019

    Report

    Report Number
    2024168-2019-03347
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    March 27, 2019
    Report Date
    April 26, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648151644
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION BLUE, SION BLACK, GUIDE CATHETER: HYPERION AL 1.0. 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 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 90% STENOSED, MODERATELY TORTUOUS AND MILDLY CALCIFIED CONCENTRIC LESION IN THE BELOW BIFURCATION POSTERIOR DESCENDING CORONARY ARTERY. FOLLOWING PRE-DILATATION WITH A NON-ABBOTT BALLOON DILATATION CATHETER (BDC), A 2.0 X 12 MM NC TREK RX BDC WAS ADVANCED; HOWEVER, RESISTANCE WAS MET WITH THE CALCIFIED LESION DURING ADVANCEMENT. DURING THE FOURTH INFLATION OF THE NC TREK RX BDC, THE BALLOON RUPTURED AT 16 ATMOSPHERES. THE NC TREK RX BDC WAS REMOVED FROM THE PATIENT ANATOMY WITHOUT RESISTANCE. A NON-ABBOTT BDC WAS USED FOR ADDITIONAL PRE-DILATATION AND THE PROCEDURE WAS COMPLETED WITH A DRUG COATED BALLOON. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347449 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 80117G1 08717648151644

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR