BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3041736 · Received April 8, 2013

    Report

    Report Number
    2024168-2013-02095
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    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 REPORTED BALLOON RUPTURE WAS CONFIRMED. BASED ON VISUAL AND SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: ATHLETE PREMIUM, EEL LIGHT, GLANDSLAM; GUIDING CATH: TAIGA JL4. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE NC TREK MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURING NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED, 90% STENOSIS IN THE LEFT MAIN (LMT) AND THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE 2.0X15MM MINI TREK RX BALLOON CATHETER WAS ADVANCED WITHOUT RESISTANCE AND INFLATED; HOWEVER, THE BALLOON RUPTURED ON THE SECOND INFLATION AT 14 ATMOSPHERES. THEREFORE, A 2.25X15MM NC TREK WAS ADVANCED WITHOUT RESISTANCE AND INFLATED; HOWEVER, IT RUPTURED DURING THE THIRD INFLATION AT 18 ATMOSPHERES. THERE WAS NO RESISTANCE REMOVING THE BALLOON CATHETERS. A 3.5X28MM XIENCE PRIME CROSSED THE LESION AND THE PROCEDURE WAS COMPLETED AFTER THE KISSING BALLOON TECHNIQUE WITH A TREK RX 2.5X15MM AND A NON-ABBOTT 3.5X15MM BALLOON CATHETER. 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
    143110 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21122G1

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR