BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2950384 · Received February 8, 2013

    Report

    Report Number
    2024168-2013-00739
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 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. 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-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 LESION IN LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 99% STENOSIS, MODERATE TORTUOSITY AND HEAVY CALCIFICATION. A 1.2 X 6 MM TREK RX BALLOON CROSSED AND WAS USED TO PRE-DILATE THE LESION FIRST. THEN THE 2.5 X 15 MM TREK RX BALLOON WAS ADVANCED FOR FURTHER PRE-DILATATION, HOWEVER, IT COULD NOT CROSS. A 2.0 X 12 MM NON-ABBOTT BALLOON CROSSED AND WAS USED TO PERFORM FURTHER PRE-DILATATION. THE 2.5 X 15 MM TREK BALLOON WAS ADVANCED AGAIN, AND THIS TIME, SUCCESSFULLY CROSSED. HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. NO RESISTANCE WAS NOTED DURING RETRACTION OF THE DEVICE. A 2.5 X 15 MM NC TREK BALLOON WAS USED TO PERFORM FURTHER PRE-DILATATION AND A NON-ABBOTT STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54039 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20919G1

    Patients

    Seq Age Sex Outcome Treatment
    1