BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 4122636 · Received September 26, 2014

    Report

    Report Number
    2024168-2014-06237
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    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. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED PATIENT EFFECT OF DISSECTION IS A KNOWN OBSERVED AND POTENTIAL PATIENT EFFECT AS LISTED IN THE TREK INSTRUCTION FOR USE (IFU). BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. THE 4.0X33MM XIENCE XPEDITION REFERENCED, IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 98% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). REPORTEDLY, A DISSECTION OCCURRED DURING INFLATION OF THE 3.0X20MM TREK BALLOON DILATATION CATHETER (BDC) AT 12 ATMOSPHERES (ATM). THE 4.0X33MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS SUCCESSFULLY DEPLOYED TO TREAT THE DISSECTION; HOWEVER, DURING WITHDRAWAL OF THE SDS, RESISTANCE WAS MET WITH THE GUIDING CATHETER, SLIGHT FORCE WAS APPLIED, AND THE DISTAL SHAFT SEPARATED. AS THE DISTAL SHAFT WAS STUCK IN THE GUIDING CATHETER, ALL DEVICES WERE REMOVED AS A SINGLE UNIT WITHOUT ANY REPORTED ISSUES. THE ACCESS SITE WAS CHANGED FROM RADIAL TO FEMORAL AND THE CASE WAS SUCCESSFULLY COMPLETED. ALTHOUGH THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS, THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE NEED TO CHANGE ACCESS SITE AND GUIDING CATHETER. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601923 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 31021G1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention