BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

    MDR report key: 2873679 · Received December 14, 2012

    Report

    Report Number
    2024168-2012-07927
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE DEVICE WAS RETURNED FOR ANALYSIS. THE BALLOON RUPTURE WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL INSPECTION AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    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. THE ADDITIONAL VIATRAC PLUS REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE LEFT RENAL ARTERY WITH MODERATE CALCIFICATION AND A SEVERE TAKEOFF. THE FIRST VIATRAC PLUS BALLOON WAS ADVANCED FOR PRE-DILATATION OF THE LESION. HOWEVER, IT RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THE SECOND VIATRAC PLUS BALLOON WAS ADVANCED. HOWEVER, IT ALSO RUPTURED DURING THE FIRST INFLATION AT 8 ATM. NO RESISTANCE WAS REPORTED DURING ADVANCEMENT OR RETRACTION OF EITHER BALLOON. A HERCULINK ELITE 5 X 12 X 80 MM STENT WAS THEN ADVANCED WITHOUT ISSUE AND IMPLANTED. THE NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 2021561

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR