BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 2872147 · Received December 13, 2012

    Report

    Report Number
    2024168-2012-07887
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    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. GUIDE WIRE: TGV; GUIDE CATHETER: MACH1 6F; STENT: XIENCE PRIME 2.5X18. 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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED 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 PROCEDURE TO TREAT A DE NOVO, CONCENTRIC LESION IN THE DISTAL LEFT CIRCUMFLEX ARTERY WITH MILD TORTUOSITY, HEAVY CALCIFICATION AND 90% STENOSIS, PRE-DILATATION WAS PERFORMED AND A 2.5X18 XIENCE PRIME STENT WAS DEPLOYED. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED. A 2.25X15 NC TREK RX DILATATION CATHETER WAS ADVANCED WITHOUT RESISTANCE FOR POST-DILATATION AND INFLATED, THE FIRST INFLATION WAS AT 15 ATMOSPHERES (ATMS), HOWEVER, DURING THE SECOND INFLATION THE BALLOON RUPTURED AT 15 ATMS. THE 2.25X15 NC TREK RX DILATATION CATHETER WAS WITHDRAWN FROM THE PATIENT ANATOMY WITHOUT RESISTANCE AND ANOTHER NC TREK WAS USED FOR FURTHER POST-DILATATION. REPORTEDLY, IVUS AND POST DILATATION WERE PERFORMED AS PART OF STANDARD PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ANY ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 2031661

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR