BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2851834 · Received November 29, 2012

    Report

    Report Number
    2024168-2012-07571
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CATALOG # - CORRECTION, MANUFACTURING SITE - CORRECTION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED INFLATION ISSUE 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITH AN INTERVENTIONAL PROCEDURE THE MINI TREK BALLOON DILATATION CATHETER WOULD NOT INFLATE. THERE WAS NO ADVERSE PATIENT EFFECT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE 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 20613G1

    Patients

    Seq Age Sex Outcome Treatment
    1