BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3202569 · Received July 2, 2013

    Report

    Report Number
    2024168-2013-04146
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    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). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE REPORTED RESISTANCE AND BALLOON RUPTURE APPEAR TO BE RELATED TO THE CASE CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 THE NC TREK 2.5X12 WAS ADVANCED THROUGH RADIAL ACCESS. DURING ADVANCEMENT, RESISTANCE WAS MET, BUT THE BALLOON WAS PLACED IN THE DISTAL RIGHT CORONARY ARTERY TARGET LESION AND INFLATION WAS ATTEMPTED. THE BALLOON RUPTURED AT 5 TO 6 ATMOSPHERES WITH THE FIRST INFLATION. THE BALLOON WAS REPLACED WITH AN NC TREK 3.0 AND A NON-ABBOTT STENT WAS IMPLANTED WITHOUT FURTHER INCIDENT. THE PHYSICIAN COMMENTED THAT THERE WAS NO PROBLEM FOUND AT AIR ASPIRATION OF THE 2.5X12 NC TREK PRIOR TO THE USE AND THE LESION WAS HEAVILY CALCIFIED, WHICH MAY HAVE INFLUENCED THE RUPTURE OF THE BALLOON. BALLOON RUPTURE WAS CONFIRMED WHEN IT WAS ATTEMPTED TO INFLATE THE BALLOON OUTSIDE OF THE PATIENT BODY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300891 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2050161

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: SION BLUE, GUIDE CATHETER: HEARTRAIL