BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3870745 · Received June 12, 2014

    Report

    Report Number
    2024168-2014-03782
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 28, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT LEAK AND INFLATION ISSUE WERE 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 THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT FOR SHAFT LEAK OR INFLATION ISSUES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE HEAVILY TORTUOUS RIGHT CORONARY ARTERY (RCA). AN ATTEMPT WAS MADE TO TREAT THE LESION WITH AN UNSPECIFIED CUTTING BALLOON CATHETER; HOWEVER, THE CUTTING BALLOON CATHETER COULD NOT CROSS THE LESION. THE 2.0X15MM MINI TREK BALLOON DILATATION CATHETER (BDC) WAS UNPACKAGED AND PREPPED WITHOUT ISSUE. REPORTEDLY, THERE WAS NO RESISTANCE DURING REMOVAL OF THE STYLET OR PROTECTIVE SHEATH. THE MINI TREK BDC WAS SUCCESSFULLY ADVANCED TO THE LESION; HOWEVER, THE BDC COULD NOT BE INFLATED AND WAS WITHDRAWN WITHOUT REPORTED ISSUE. OUTSIDE THE PATIENT'S ANATOMY, A LEAK WAS NOTED IN THE SHAFT OF THE BDC. ANOTHER 2.0X15MM MINI TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348395 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40205G1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR