BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3951325 · Received July 22, 2014

    Report

    Report Number
    2024168-2014-04702
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    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. 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 INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MILDLY TORTUOUS, HEAVILY CALCIFIED, 99% STENOSED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY PROCEDURE, THE 2.0 X 15 MM MINI TREK BALLOON DILATATION CATHETER MET RESISTANCE DURING ADVANCEMENT TO THE DISTAL LAD LESION AND ONLY REACHED JUST PAST THE LAD OSTIUM. THE BALLOON WAS INFLATED ONCE AND RUPTURED AT 8 ATMOSPHERES (ATM). ANOTHER NON-ABBOTT BALLOON WAS USED AND FAILED TO CROSS TO THE DISTAL LAD. THEN ROTABLATORS WERE USED TO BREAK DOWN THE CALCIFICATION IN THE LESION. THEN THE LESION WAS SUCCESSFULLY DILATED WITH NON-SPECIFIED BALLOONS AND THREE XIENCE XPEDITION STENTS WERE USED TO SUCCESSFULLY COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428917 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30926G1

    Patients

    Seq Age Sex Outcome Treatment
    1