BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 2936060 · Received January 30, 2013

    Report

    Report Number
    2024168-2013-00494
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE FOX CROSS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER INSTRUCTIONS FOR USE STATES: DO NOT ADVANCE THE FOXCROSS PTA CATHETER AGAINST SIGNIFICANT RESISTANCE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT COMMON CAROTID ARTERY. A 7 X 40 MM FOXCROSS WAS ADVANCED TO THE LESION AND INFLATED TO 12 ATMOSPHERES. A SECOND INFLATION WAS BEING PERFORMED WHEN THE BALLOON RUPTURED AT 8 ATMOSPHERES. THERE WAS DIFFICULTY REMOVING THE CATHETER FROM THE GUIDE WIRE AND THE BALLOON SEPARATED AND REMAINED IN THE ANATOMY. THE BALLOON COULD NOT BE REMOVED; THEREFORE, THE PATIENT WAS SENT TO SURGERY TO EXTRACT THE BALLOON. THE SURGERY WAS SUCCESSFUL AND THE PATIENT IS FINE AND HAS BEEN DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40408 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 769242

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R