BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA 2 MONORAIL CUTTING BALLOON

    MDR report key: 1051490 · Received May 13, 2008

    Report

    Report Number
    2134265-2008-01391
    Event Type
    Injury
    Date Received
    May 13, 2008
    Date of Event
    February 28, 2008
    Report Date
    April 14, 2008
    Manufacturer
    BSC LETTERKENNY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    PER FACILITY MEDWATCH REPORT, IT WAS REPORTED THAT DURING A CARDIAC CATHETER STENTING PROCEDURE A BALLOON RUPTURE AND SLOW REFLOW PHENOMENA OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). PREDILATION WAS COMPLETED WITH A 2.5 X 20 MAVERICK BALLOON. ATTEMPTS WERE MADE TO CROSS A 3.0 X 24 AND 3.0 X 16 TAXUS DRUG-ELUTING STENTS WITHOUT SUCCESS, AS WELL AS ANOTHER MFR'S 3.0 X 15 STENT. THEREFORE, THE 3.0 X 10 ULTRA 2 CUTTING BALLOON WAS INSERTED AND INFLATED TO 6 ATMS. HOWEVER, THE BALLOON RUPTURED AND "THERE WAS A SHOWER OF DEBRIS FROM THE BALLOON." THERE WAS SLOW REFLOW PHENOMENA WITH ST SEGMENT ELEVATION THAT RESPONDED TO IV FLUIDS AND PRESSORS. THE ST SEGMENT ELEVATION WAS TRANSIENT. ATROPINE WAS GIVEN FOR BRADYCARDIA, AND LOW DOSE DOPAMINE FOR RELATIVE HYPOTENSION. SEVERAL STENTS WERE THEN PLACED SUCCESSFULLY WITH MARKED IMPROVEMENT ANGIOGRAPHICALLY AND RESOLUTION OF HER ST SEGMENT ELEVATION AND RESOLUTION OF TIMI 3 FLOW. THERE WAS EVIDENDE OF PLAQUE SHIFTING DISTALLY; IT WAS UNK IF THIS WAS TRUE PLAQUE OR DEBRIS THAT HAD EMBOLIZED. THIS WAS BALLOONED WITH "EXCELLENT APPEARANCE OF THE VESSEL". PT IS TO CONTINUE ON PLAVIX FOR AT LEAST A YEAR AND ASPIRIN INDEFINITELY. PT STATUS REPORTED AS 'OKAY'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA 2 MONORAIL CUTTING BALLOON LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO LOX BSC LETTERKENNY NA EJ0002

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 3.0 X 15 VISION STENT