BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3864139 · Received June 10, 2014

    Report

    Report Number
    2024168-2014-03709
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE BALLOON RUPTURE WAS CONFIRMED. BASED ON VISUAL AND SCANNING ELECTRON MICROSCOPY IMAGING 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. 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 RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC, DE NOVO, 99% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY. REPORTEDLY, DURING PRE-DILATATION THE 2.5 X 15MM RX TREK BALLOON RUPTURED DURING THE SECOND INFLATION AT 14 ATMOSPHERES. POSSIBLE MISSING PIECE OF THE BALLOON, AS THE BALLOON RUPTURED VERTICALLY. THE PROCEDURE WAS COMPLETED BY IMPLANTING A DRUG-ELUTING STENT IN THE LESION. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR RETRACTION OF THE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. *RETURN DEVICE ANALYSIS CONFIRMED THAT THERE ARE NO MISSING BALLOON PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338043 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40211G1

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: SION BLUE