BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 4884933 · Received July 1, 2015

    Report

    Report Number
    2024168-2015-03692
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    June 2, 2015
    Report Date
    September 1, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) INFLATED ABOVE RATED BURST PRESSURE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SEPARATION AND RUPTURE WERE CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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. IT WAS REPORTED THAT THE NC TREK BALLOON WAS INFLATED TO 26 ATMOSPHERES (ATM). IT SHOULD BE NOTED THAT THE NC TREK RX INSTRUCTIONS FOR USE (IFU) WARNS: BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE (RBP). THE RBP FOR THE NC TREK RX DEVICE IS 18 ATM; THEREFORE, RBP WAS EXCEEDED. IN THIS CASE, IT IS LIKELY THE BALLOON DILATATION CATHETER BEING INFLATED ABOVE RBP CONTRIBUTED TO THE BALLOON RUPTURING, BALLOON/SHAFT/MARKER SEPARATION AND NOTED STRETCHING. BASED ON THE REPORTED INFORMATION, THE MANUFACTURING RECORDS AND SIMILAR INCIDENTS ANALYSIS, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY CALCIFIED, DE NOVO, PROXIMAL RIGHT CORONARY ARTERY (RCA), THE NC TREK BALLOON DILATATION CATHETER WAS USED ONCE AT 26 ATMOSPHERE (ATM) FOR 30 SECONDS AND RUPTURED. THE DISTAL PART OF THE BALLOON BETWEEN THE MARKERS DETACHED. UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE DETACHED SEGMENT. THE DETACHED SEGMENT WAS EMBEDDED IN THE VESSEL WITH A NON-ABBOTT STENT. THE PATIENT CONDITION WAS NOTED TO BE GOOD. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424639 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 50130G1

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention