BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3081338 · Received April 26, 2013

    Report

    Report Number
    2024168-2013-02621
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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) - INFLATION ABOVE RATED BURST PRESSURE (RBP). 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-CONFORMANCE 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 INSTRUCTION FOR USE (IFU) STATES: BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE (RBP). USE OF A PRESSURE-MONITORING DEVICE IS RECOMMENDED TO PREVENT OVER-PRESSURIZATION. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE ECTATIC, HEAVILY CALCIFIED, DE NOVO, 90% STENOSED, MID LEFT ANTERIOR DESCENDING (LAD) ARTERY MULTIPLE PRE-DILATATION INFLATIONS WERE COMPLETED USING A 2.5 X 12 MM TREK BALLOON DILATATION CATHETER (BDC). THE 3.0 X 23 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. ADDITIONAL PRE-DILATATION WAS PERFORMED USING A 3.0 X 15 MM TREK BDC BUT THE BALLOON RUPTURED AT 17 ATMOSPHERE (ATM). A 3.0 X 12 MM NON-ABBOTT BDC WAS USED AT 15 ATM AND 16 ATM WITHOUT ISSUE. A 3.0 X 9 MM NON-ABBOTT STENT WAS DELIVERED AND POST-DILATED WITH A 3.5 X 12 MM NON-ABBOTT BDC. A 3.5 X 15 MM XIENCE PRIME SDS WAS ATTEMPTED TO BE DELIVERED PROXIMAL TO THE 3.0 X 9 MM NON-ABBOTT STENT BUT IT COULD NOT BE DELIVERED; AFTER REMOVAL THE STENT STRUTS WERE OBSERVED TO BE LIFTED. ADDITIONAL PRE-DILATATION WAS PERFORMED AND A 3.5 X 15 MM XIENCE PRIME SDS WAS DELIVERED, DEPLOYED, AND POST-DILATATED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180795 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20911G3

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR