BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 4243437 · Received November 11, 2014

    Report

    Report Number
    2024168-2014-07335
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 21, 2014
    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 THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY 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. THE NC TREK REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED, 99% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY. REPORTEDLY, THE 2.0 X 8MM RX TREK BALLOON CATHETER (DEVICE 1) WOULD NOT CROSS THE LESION DUE TO THE ANATOMY. A NON-ABBOTT MICRO CATHETER CROSSED THE LESION. THE RX TREK (DEVICE 1) WAS ADVANCED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING FIRST INFLATION AT 12 ATMOSPHERES. A 2.5 X 12MM NC TREK BALLOON CATHETER (DEVICE 2) WAS ADVANCED SUCCESSFULLY. AN ATTEMPT TO CROSS THE LESION WITH A 3.0 X 38MM XIENCE XPEDITION (DEVICE 3) WAS MADE; HOWEVER, DID NOT CROSS THE LESION DUE TO PATIENT ANATOMY. THE PROXIMAL SHAFT WAS KINKED AT APPROXIMATELY 20 CM DISTAL TO THE HUB. THE 2.5 X 12MM NC TREK (DEVICE 2) WAS ADVANCED A SECOND TIME AND INFLATED TO 18 ATMOSPHERES; HOWEVER THE BALLOON RUPTURED. TIMI III FLOW WAS GAINED AND THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL TREATMENT. 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
    725309 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30920G1

    Patients

    Seq Age Sex Outcome Treatment
    1