BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3843772 · Received June 2, 2014

    Report

    Report Number
    2024168-2014-03530
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 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 AND THE REPORTED BALLOON RUPTURE COULD NOT BE CONFIRMED. HOWEVER, ANALYSIS NOTED A LEAK FROM A TEAR IN THE INNER MEMBER WHICH IS CONSISTENT WITH THE REPORTED INFORMATION. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR BALLOON RUPTURE INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, CONCENTRIC, DE NOVO LESION IN THE PROXIMAL CIRCUMFLEX. REPORTEDLY, DURING PRE-DILATATION, THE 3.0 X 15MM RX TREK WAS INFLATED FOR A BALLOON ANGIOPLASTY, DURING FIRST INFLATION AT 8 ATMOSPHERES. DURING SECOND INFLATION AT 8 ATMOSPHERES THE BALLOON RUPTURED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL OF THE DEVICE. A SECOND NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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
    321490 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 40115G2

    Patients

    Seq Age Sex Outcome Treatment
    1