BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2853480 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07613
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 7, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED WITH A TEAR AT THE GUIDE WIRE EXIT NOTCH; THE REPORTED LEAK WAS CONFIRMED. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY TORTUOUS, MODERATELY CALCIFIED, LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE 3.0 X 15 MM TREK RX BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE INFLATED BUT A LEAK WAS NOTED. THE DEVICE WAS REMOVED WITHOUT INCIDENT. AFTER PRE-DILATATION, A XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED BUT COULD NOT CROSS THE LESION. A 2.5 X 12 MM XIENCE V SDS WAS USED SUCCESSFULLY IN THE PROCEDURE. 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
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20911G2

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR