BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2823044 · Received November 7, 2012

    Report

    Report Number
    2024168-2012-07021
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 29, 2012
    Report Date
    October 16, 2012
    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. 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 LOCATED IN THE MODERATELY CALCIFIED, 99% STENOSED, MID LEFT ANTERIOR DESCENDING ARTERY. THE 2.0-8 MM TREK RX BALLOON CATHETER WAS ADVANCED TO THE LESION WITH NO SIGNIFICANT RESISTANCE FELT DURING ADVANCEMENT. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON UP TO 8 ATMOSPHERES (ATM); HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT LESS THAN 8 ATM. A NON ABBOTT 2.0-10 MM BALLOON CATHETER WAS USED FOR FURTHER DILATATION AND A NON-ABBOTT STENT WAS DEPLOYED, FOLLOWED BY POST-DILATATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20705G1

    Patients

    Seq Age Sex Outcome Treatment
    1