BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2822715 · Received November 7, 2012

    Report

    Report Number
    2024168-2012-07006
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 16, 2012
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: SION; GUIDE CATH: MACH1FL4. 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 FOR THIS LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC, 99% STENOSED LESION IN THE DISTAL CIRCUMFLEX WITH MODERATE TORTUOSITY AND MILD CALCIFICATION. AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS ADVANCED, BUT COULD NOT CROSS TO THE LESION. THE 3.0 X 15 MM TREK BALLOON WAS PREPARED PER THE INSTRUCTIONS FOR USE, AND ADVANCED TO THE LESION. THE BALLOON WAS INFLATED TO 12 ATMOSPHERES (ATM); HOWEVER, DURING THE SECOND INFLATION OF 12 ATM, THE BALLOON RUPTURED. THE TREK WAS REMOVED WITHOUT ISSUE. A NEW BALLOON WAS USED TO DILATE THE LESION TO 20 ATM, AND A XIENCE PRIME STENT WAS IMPLANTED SUCCESSFULLY. 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
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20227G1

    Patients

    Seq Age Sex Outcome Treatment
    1