BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3800858 · Received May 8, 2014

    Report

    Report Number
    2024168-2014-02943
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 14, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DEVICE DEFECT (BALLOON DAMAGE, COLLAPSED) COULD NOT BE CONFIRMED. BASED ON THE ANALYSIS OF THE DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE TREK 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 100% STENOSED MID RIGHT CORONARY ARTERY (RCA) AND THE PROXIMAL POSTERIOR LATERAL ARTERY. A 2.75 X 15 MM RX TREK WAS USED FOR PRE-DILATATION AND A STENT WAS IMPLANTED; HOWEVER, THROMBOSIS WAS SEEN IN THE RIGHT POSTERIOR LATERAL ARTERY. THE BALLOON WAS FOUND TO HAVE A DEFECT. A 2.25 X 20 MM RX TREK BALLOON CATHETER WAS USED TO TREAT THE POSTERIOR LATERAL ARTERY WHEN EXTRAVASATUM APPEARED. RECANALIZATION WAS STOPPED AND ANGIOGRAPHY SHOWED THE BLOOD FLOW RESUMED TO THE RCA AND THE BLOOD FLOW IN THE POSTERIOR LATERAL WAS TIMI 1-2. THERE WAS NO DEFECT OF THE ARTERY, WITH SOME EXTRAVASATUM EXISTING. THE PATIENT WAS SUCCESSFULLY TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277852 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30810G1

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention