BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 2981458 · Received February 27, 2013

    Report

    Report Number
    2024168-2013-01156
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 4, 2013
    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). 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 THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN A SHUNT VESSEL THAT HAD MODERATE TORTUOSITY, HEAVY CALCIFICATION AND WAS 75% STENOSED. THE FOX CROSS BALLOON CATHETER CROSSED THE LESION; HOWEVER, THE BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THE BALLOON CATHETER TO THE LESION. A NEW FOX SV WAS USED FOR FURTHER DILATATION AND THE PROCEDURE WAS COMPLETED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85008 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 726802

    Patients

    Seq Age Sex Outcome Treatment
    1