BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3011389 · Received March 19, 2013

    Report

    Report Number
    2024168-2013-01579
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: RUNTHROUGH, SION BLUE, XT-R; GUIDE CATH: BRITE TIP 6F AL1, CORSAIR; STENT: PROMUS ELEMENT 2.25X20MM. (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. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT WAS REPORTED THAT THE DEVICE WAS PREPARED INSIDE THE PATIENT ANATOMY. IT SHOULD BE NOTED THAT THE (B)(4) NC 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. 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, 99% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE 2.0 X 15 MM TREK BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION OF A NON-ABBOTT STENT, WITHOUT RESISTANCE; HOWEVER, THE BALLOON RUPTURED AT THE THIRD INFLATION OF 18 ATMOSPHERES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADDITIONAL INFLATIONS. 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
    114712 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21002G1

    Patients

    Seq Age Sex Outcome Treatment
    1