BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 6909545 · Received October 3, 2017

    Report

    Report Number
    2024168-2017-07928
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 26, 2017
    Report Date
    October 2, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    UDI-DI
    08717648151965
    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). MEDICAL PRODUCTS: GUIDE WIRE: SION, GUIDE CATH: HYPERION, STENT: ULTIMASTER 3.0X38MM. 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 THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO, ECCENTRIC LESION WITH MODERATE TORTUOSITY, MODERATE CALCIFICATION AND 90% STENOSIS IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. AFTER A GUIDE WIRE CROSSED, PRE-DILATATION WAS PERFORMED WITH A 2.0 X 15 MM NON-ABBOTT BALLOON CATHETER AND A 3.0 X 38 MM NON-ABBOTT STENT WAS IMPLANTED AT THE LESION. INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED THE PROXIMAL STENT STRUT WAS NOT EMBEDDED, SO A 3.5 X 8 MM NC TREK BALLOON CATHETER WAS ADVANCED FOR THE ADDITIONAL DILATATION. HOWEVER, THERE WAS RESISTANCE WITH THE IMPLANTED STENT DURING ADVANCEMENT AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATMS). THE DEVICE WAS CHANGED TO A 3.5 X 6 MM NON-ABBOTT BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ADVERSE EFFECT AND NO REPORT OF CLINICALLY SIGNIFICANT DELAY DUE TO THE BALLOON RUPTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689484 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 70512G1 08717648151965

    Patients

    Seq Age Sex Outcome Treatment
    1