BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2991195 · Received March 6, 2013

    Report

    Report Number
    2024168-2013-01290
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE REPORTED LEAK AND INFLATION DIFFICULTY WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS LESION IN THE CORONARY ARTERY. THE 3.0 X 15 MM TREK BALLOON WAS ADVANCED TO THE LESION WITHOUT ISSUE AND ATTEMPTED TO BE INFLATED, BUT THE BALLOON DID NOT INFLATE. THE DEVICE WAS REMOVED WITHOUT RESISTANCE. AFTER REMOVAL, IT WAS FOUND THAT THERE WAS A LEAK AT THE GUIDE WIRE EXIT NOTCH. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96253 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20528G1

    Patients

    Seq Age Sex Outcome Treatment
    1