BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3935271 · Received July 15, 2014

    Report

    Report Number
    2024168-2014-04522
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 20, 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 ANALYSIS AND THE HYPOTUBE WAS IDENTIFIED TO BE SEPARATED. THE BALLOON WAS INFLATED AND HELD PRESSURE WITH NO RUPTURE. THE REPORTED BALLOON RUPTURE COULD NOT BE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO ASSOCIATED NON-CONFORMING MATERIAL REPORTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR INCIDENTS REPORTED FOR 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 ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED, CONCENTRIC, DE NOVO, 90% STENOSIS IN THE CORONARY LESION. REPORTEDLY, THE 2.5 X 15MM RX TREK BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING FIRST INFLATION AT 6 ATMOSPHERES. A SECOND 2.5 X 15MM NC TREK BALLOON CATHETER WAS USED TO COMPLETE PRE-DILATATION. THE PROCEDURE WAS COMPLETED AFTER DEPLOYMENT OF A STENT. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL OF THE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413731 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40127G1

    Patients

    Seq Age Sex Outcome Treatment
    1