BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 3803157 · Received May 9, 2014

    Report

    Report Number
    2024168-2014-02969
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TREATMENT OF A MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY, THE DEVICE WAS PREPARED FOR USE OUTSIDE OF THE ANATOMY AND THE BALLOON WAS SOAKED IN NORMAL SALINE PRIOR TO USE. REPORTEDLY, DURING PRE-DILATATION OF THE VESSEL THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. A SAME SIZED NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO PRE-DILATE THE VESSEL. THE PHYSICIAN BELIEVED THAT THE BALLOON RUPTURE OCCURRED DUE TO THE CALCIFIED LESION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281684 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 824749

    Patients

    Seq Age Sex Outcome Treatment
    1