BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3031741 · Received April 2, 2013

    Report

    Report Number
    2024168-2013-01937
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET 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 ANALYSIS AND THE REPORTED BALLOON RUPTURE WAS CONFIRMED. BASED ON VISUAL 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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-DILATATION IN THE NON-CALCIFIED/NON-TORTUOUS DISTAL LEFT CIRCUMFLEX ARTERY, A 2.0X12 NC TREK BALLOON WAS INFLATED ONE TIME TO 18 ATMOSPHERES AND THE BALLOON RUPTURED. A DISSECTION OCCURRED; THEREFORE, A 2.5X12 NC TREK BALLOON WAS INFLATED TO 18 ATMOSPHERES IN THE LEFT CIRCUMFLEX ARTERY AND A 2.5X23 XIENCE PRIME STENT WAS IMPLANTED SUCCESSFULLY AT THE LOCATION OF THE DISSECTION/LESION. THE PROCEDURE WAS COMPLETED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL OF THE DEVICE AND NO FORCE WAS APPLIED. ALTHOUGH THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133745 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2021561

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention