BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3923877 · Received July 9, 2014

    Report

    Report Number
    2024168-2014-04423
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 2014
    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): INCORRECT PREP. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. BECAUSE IT WAS REPORTED THAT AIR-BLEEDING WAS PERFORMED INSIDE THE PATIENT BODY, IT SHOULD BE NOTED THAT THE PREPARATION FOR USE SECTION OF THE RX TREK CORONARY DILATATION CATHETER INSTRUCTIONS FOR USE STATES: ALL AIR MUST BE REMOVED FROM THE BALLOON AND DISPLACED WITH CONTRAST PRIOR TO INSERTING INTO THE BODY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS FOR BALLOON RUPTURE REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC, DE NOVO, 99% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). REPORTEDLY, THE 3.5 X 15MM NC TREK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING FIRST INFLATION AT 14 ATMOSPHERES. A SECOND 3.5 X 15MM NC TREK BALLOON CATHETER WAS USED BUT ALSO RUPTURED DURING SECOND INFLATION AT 14 ATMOSPHERES. NO FURTHER ATTEMPTS WERE MADE FOR PRE-DILATATION. SLIGHT RESISTANCE WAS MET DURING ADVANCEMENT DUE TO THE HEAVY CALCIFIED LESION. THERE WAS NO RESISTANCE NOTED DURING REMOVAL. THE PROCEDURE WAS COMPLETED AFTER DEPLOYMENT OF AN ABBOTT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401143 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 31023G1

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BALANCE