BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2932010 · Received January 28, 2013

    Report

    Report Number
    2024168-2013-00447
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 7, 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. (B)(4). THE 3.0 X 8 MM RX NC TREK REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. 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 THIS COMPLAINT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. 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 DURING THE PROCEDURE IN THE HEAVILY CALCIFIED LEFT CIRCUMFLEX ARTERY, PREDILATATION WAS PERFORMED USING A NON-ABBOTT BALLOON. AN UNSPECIFIED DRUG-ELUTING STENT WAS DEPLOYED. ATHERECTOMY WAS PERFORMED USING A NON-ABBOTT DEVICE. POST DILATATION WAS ATTEMPTED USING A 3.0X8 NC TREK BALLOON AND A 2.75X12 NC TREK BALLOON; HOWEVER, BOTH BALLOONS RUPTURED DURING THE FIRST INFLATION WHEN PRESSURE WAS INCREASED FROM 10 ATMOSPHERES TO 14 ATMOSPHERES. OTHER UNSPECIFIED BALLOONS ALSO RUPTURED DURING DILATATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. REPORTEDLY, THE ABBOTT BALLOONS WERE PREPPED INSIDE THE ANATOMY BEFORE DILATATION WAS PERFOMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37328 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2072561

    Patients

    Seq Age Sex Outcome Treatment
    1