BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA 2 MONORAIL CUTTING BALLOON

    MDR report key: 1192363 · Received October 2, 2008

    Report

    Report Number
    2134265-2008-02864
    Event Type
    Injury
    Date Received
    October 2, 2008
    Report Date
    September 16, 2008
    Manufacturer
    BSC LETTERKENNY
    Product Code
    LIT
    PMA / PMN Number
    p950020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN REC'D FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FORM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY MED WATCH FORM REPORT THAT A BALLOON CATHETER TIP DETACHED. "PT UNDERGOING A RIGHT PROXIMAL FEMORAL POPLITEAL BYPASS GRAFT BALLOON ANGIOPLASTY WITH A 4 X 15 CUTTING BALLOON. DUE TO THE PRESENCE OF AN AORTOBIFEMORAL BYPASS GRAFT, THE APPROACH WAS LEFT AXILLARY. A 5FR SHEATH WAS PLACED. A CATHETER AND J WIRE WERE USED, THEN EXCHANGED FOR ANOTHER CATHETER AND ANGLED GLIDEWIRE. BALLOON ANGIOPLASTY WAS DONE USING A 0.014 WIRE AND A 4 X 15 MM CUTTING BALLOON. INFLATED MULTIPLE TIMES UP TO 8 ATMOSPHERES. AFTER DILATING WAS COMPLETE, THE BALLOON WAS REMOVED FROM THE SHEATH, IT WAS NOTED THAT THE TIP WAS MISSING. ANGIOGRAM SHOWED STENOSIS RESOLVED. RADIOPAQUE MARKERS OF THE BALLOON WERE SEEN IN THE DISTAL ASPECT OF THE GRAFT. RETRIEVAL ATTEMPT WITH A SNARE. SIZED UP TO 6 FR SHEATH 30 CM SHEATH. A 135 CM SNARE WAS USED, 2 MM THEN A 7 MM SNARE. TIP OF BALLOON WAS SNARED, AND BROUGHT UP TO LEFT AXILLA. UNABLE TO PASS THE TIP OF THE BALLOON INTO THE SHEATH. PROCEDURE STOPPED. CONSENT OBTAINED FOR LEFT AXILLARY EXPLORATION. PROCEDURE DONE UNDER GENERAL ANESTHESIA. SMALL INCISION MADE AND ARTERY EXPOSED AND OPENED. SHEARED OFF PORTION OF CUTTING BALLOON WAS RETRIEVED FROM VESSEL." "REPAIR OF ARTERIOTOMY COMPLETED. IT APPEARS THAT THE BALLOON HAD SHEARED OFF AT THE POINT OF THE WIRE EXIT FROM THE MONORAIL PORTION OF THE BALLOON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA 2 MONORAIL CUTTING BALLOON LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOU LIT BSC LETTERKENNY NA EJ0027

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention