BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2781403 · Received October 10, 2012

    Report

    Report Number
    2024168-2012-06400
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 20, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED INFLATION DIFFICULTY WAS NOT CONFIRMED. THE BALLOON INFLATED TO RATED BURST PRESSURE WITH NO ANOMALIES. BASED ON VISUAL AND FUNCTIONAL ANALYSIS, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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 DURING A HEAVILY CALCIFIED CIRCUMFLEX ARTERY INTERVENTION THE TREK BALLOON DILATATION CATHETER WAS TAKEN TO THE LESION AND INFLATED; HOWEVER, PER ANGIOGRAM, THERE WAS NO CHANGE TO THE LESION. IT IS POSSIBLE THAT THE BALLOON RUPTURED DURING INFLATION. UPON REMOVAL OF THE DEVICE FROM THE ANATOMY, IT WAS CLEAR THAT THE BALLOON HAD BEEN INFLATED. THERE WAS NO ADVERSE SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER TREK BALLOON DILATATION CATHETER. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20417G2

    Patients

    Seq Age Sex Outcome Treatment
    1