BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 2914429 · Received January 14, 2013

    Report

    Report Number
    2024168-2013-00285
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE RESISTANCE WAS ABLE TO BE CONFIRMED HOWEVER THE FLAT BALLOON WAS NOT ABLE TO BE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (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

    SUBSEQUENT TO FILING THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE PROCEDURE WAS TO TREAT A LESION IN THE POPLITEAL ARTERY. UPON THE REMOVAL OF THE FOX PLUS FROM THE PATIENT, THE BALLOON APPEARED FLAT/NOT RE-FOLDED. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DRUG-ELUTING BALLOON, WITH SATISFACTORY RESULTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DEFLATION, THE FOX PLUS BALLOON (12MM X 20MM X 135CM) COULD NOT BE RETRACTED BACK THROUGH THE SHEATH. THE BALLOON WAS REMOVED FROM THE ANATOMY TOGETHER WITH THE SHEATH AS ONE UNIT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20035 FOX PLUS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 783084

    Patients

    Seq Age Sex Outcome Treatment
    1