BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 3092627 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02772
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    November 8, 2012
    Report Date
    March 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION. THE DEVICE WILL NOT BE RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. (B)(4).

    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 AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. IT WAS REPORTED THAT THE PATIENT HAD PREVIOUSLY UNDERWENT FIVE SESSIONS OF ANGIOPLASTY OVER TWO MONTHS, DUE TO A LARGE PSEUDOANEURYSM AT THE ARTERIAL LIMB. THE PATIENT RECEIVED A NON-ABBOTT STENT GRAFT AT THE ARTERIAL LIMB NEAR THE APEX. HOWEVER, STENT GRAFT THROMBOSIS OCCURRED AGAIN ONE MONTH LATER AND THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY. ALSO, T-SHAPED BALLOON ANGIOPLASTY WAS ATTEMPTED WITH AN UNSPECIFIED FOX CROSS BALLOON CATHETER, BY ROTATING AND ADVANCING THE BALLOON CATHETER TOWARD THE CONTRALATERAL LIMB WITH AN INTRODUCER SHEATH AND BENDING THE SHAFT OF THE BALLOON CATHETER TO ASSUME A "T" SHAPE. THE FOX CROSS BALLOON CATHETER ENCOUNTERED RESISTANCE WITH THE IMPLANTED NON-ABBOTT STENT GRAFT, AS IT WAS BECOMING CAUGHT IN THE MESH OF THE STENT GRAFT. THE BALLOON WAS WITHDRAWN AND BALLOON ANGIOPLASTY WAS PERFORMED THROUGH A SECOND VASCULAR ACCESS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WERE NO COMPLICATIONS REPORTED IN THE RECOVERY ROOM, POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194840 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR STENT: S & G BIOTECH STENT GRAFT