BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 2874184 · Received December 14, 2012

    Report

    Report Number
    2024168-2012-07956
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    September 27, 2012
    Report Date
    November 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A POST MARKET EVALUATION CASE THAT THE PUSH TRANSMISSION AND THE DEFLATION TIME OF THE FOXCROSS CATHETER IS SOMEWHAT WORSE COMPARED TO A NON-ABBOTT BALLOON DILATATION CATHETER. ALTHOUGH THERE WAS NO REPORTED ISSUE WITH DEFLATION, THE BALLOON DEFLATION TIME IS SLOWER THAN THE NON-ABBOTT BALLOON; HOWEVER, THE SAME AS OTHER FOXCROSS BALLOONS. A DISSECTION OCCURRED DURING THE FIRST INFLATION OF THE BALLOON, WHICH REQUIRED ADDITIONAL INFLATIONS FOR TREATMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 778897

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention