BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRA 2 MONORAIL CUTTING BALLOON

    MDR report key: 1062440 · Received June 18, 2008

    Report

    Report Number
    2134265-2008-01724
    Event Type
    Death
    Date Received
    June 18, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BSC LETTERKENNY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE CUTTING BALLOON 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 PROD 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

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, INFLATION DIFFICULTIES WERE ENCOUNTERED. THE LESION BEING TREATED WAS IN-STENT RESTENOSIS OF ANOTHER MFR'S STENT LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE ULTRA 2 MONORAIL CUTTING BALLOON WAS ADVANCED AND INFLATED 2 TIMES IN THE PROXIMAL/MID STENT WITHOUT ISSUE. THE PT STARTED EXPERIENCING EKG SYMPTOMS, SO THE PHYSICIAN WITHDREW THE BALLOON. THE SYMPTOMS RESOLVED WITHIN 2-3 MINS SO THE PHYSICIAN AGAIN ADVANCED THE ULTRA2 MONORAIL CUTTING BALLOON INTO THE DISTAL PORTION OF THE STENT. THE ULTRA2 MONORAIL CUTTING BALLOON DID NOT INFLATE, WITH CONTRAST EXTRAVASATION CONFIRMED VISUALLY. THE PT'S PRESSURE THEN DROPPED TO 50, WITH NO FLOW OCCURRING IN THE LAD/CIRCUMFLEX (CX). THE PHYSICIAN COULD NOT FIND ANY EVIDENCE OF VESSEL INJURY. HE ADVANCED AN UNSPECIFIED BALLOON, INFLATED ("TAPPED") IT A COUPLE OF TIMES, THE PT WAS GIVEN EPINEPHRINE, AND FULL FLOW WAS RESTORED. HOWEVER, THE PT NEVER RECOVERED FROM REFRACTORY VENTRICULAR FIBRILLATION. CAUSE OF DEATH WAS VENTRICULAR FIBRILLATION. THE PHYSICIAN IS UNCLEAR AS TO WHAT CAUSED THE ISSUES, BUT STATED THAT HE DOES "NOT BELIEVE THAT THE CUTTING BALLOON HAD ANYTHING TO DO WITH THE CASE".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death