BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2843060 · Received November 21, 2012

    Report

    Report Number
    2024168-2012-07405
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 30, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. 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 COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. THE ADDITIONAL TREK OTW, IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NON-HUMAN (ANIMAL-PIG) EXPERIMENTAL INTERVENTIONAL PROCEDURE OF A NON-CALCIFIED, MODERATELY TORTUOUS, LEFT ANTERIOR DESCENDING ARTERY, A TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE AND RUPTURED WHEN INFLATED TO 9 ATMOSPHERES. THE TREK BDC WAS REMOVED AND ANOTHER SAME SIZE TREK BDC WAS ADVANCED WITHOUT RESISTANCE AND RUPTURED WHEN INFLATED TO 9 ATMOSPHERES TOO. THE TREK BDC WAS REMOVED AND ANOTHER SAME SIZE TREK BDC WAS ADVANCED AND ONLY INFLATED TO 8 ATMOSPHERES TO SUCCESSFULLY DILATE THE LESION. THERE WAS NO ADVERSE SEQUELA OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. 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 1031261

    Patients

    Seq Age Sex Outcome Treatment
    1