BEUDAMED
    FDA Adverse Event Death Summary report: N

    XXL BALLOON DILATATION CATHETER

    MDR report key: 1033225 · Received April 11, 2008

    Report

    Report Number
    2134265-2008-01059
    Event Type
    Death
    Date Received
    April 11, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    K952063
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, 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

    SAME CASE AS MFR REPORT # 2134265-2008-01061. IT WAS REPORTED THAT DURING A SUPERIOR VENA CAVA (SVC) STENTING PROCEDURE, A BALLOON RUPTURE, PARTIAL BALLOON DETACHMENT AND MIGRATION, CATHETER WITHDRAWAL DIFFICULTY, A PERFORATION AND A DEATH OCCURRED. THE PROCEDURE WAS BEING PERFORMED TO RELIVE PRESSURE CAUSED BY AN EPITHELIOID HEMANGIOENDOTHELIOMA WHICH CONTRIBUTED TO A 4CM LONG, 85% STENOSED LESION LOCATED IN THE SVC, CONSTRICTING THE SVC TO 2MM IN DIAMETER. ANOTHER MFR'S 11FR INTRODUCER SHEATH WAS PLACED IN THE LEFT JUGULAR VEIN. ANOTHER MFR'S BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION OF THE LESION AND INFLATED ONE TIME TO "NOT HIGH PRESSURE" WHICH INCREASED THE DIAMETER OF THE SVC TO 12MM. A WALLSTENT 14MM X 40MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND THE STENT WAS SUCCESSFULLY DEPLOYED. THE XXL 12MM X 4M X 75CM BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION OF THE STENT AND INFLATED TO 8 ATMS ON THE FIRST INFLATION, HOWEVER, THERE WAS STILL A "WAIST" AT THE SUPERIOR MARGIN OF THE STENT. THE PHYSICIAN INCREASED THE BALLOON PRESSURE TO 10 ATMS (EXCEEDING RATED BURST PRESSURE) AT WHICH TIME THE BALLOON RUPTURED. UPON WITHDRAWAL OF THE BALLOON CATHETER, THE BALLOON CAUGHT ON A STENT STRUT AND WAS UNABLE TO BE REMOVED THROUGH THE INTRODUCER SHEATH. IN AN ATTEMPT TO REMOVE THE BALLOON CATHETER, THE PHYSICIAN APPLIED "ENOUGH FORCE TO BREAK THE CATHETER" AND, UPON REMOVAL THE BALLOON CATHETER AND SHEATH AS A UNIT, APPROX ? OF THE BALLOON MATERIAL DETACHED AND MIGRATED TO THE INNOMINATE VEIN. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DETACHED BALLOON MATERIAL UTILIZING ANOTHER MFR'S SNARE DEVICE FROM BOTH THE RIGHT AND LEFT JUGULAR VEIN BUT WAS UNSUCCESSFUL. THE PHYSICIAN NOTED A VESSEL PERFORATION IN THE SVC. IT IS UNCLEAR WHAT CAUSED THE PERFORATION. THE VESSEL PERFORATION WAS NOT TREATED AS THE PT WENT INTO FULL CARDIAC ARREST AND COULD NOT BE RESUSCITATED. THE PT EXPIRED APPROX 1 HOUR LATER. AUTOPSY REVEALED A HEMOPERICARDIUM CONTAINING 300 CC'S OF LIQUID/BLOOD AND RECORDED THE CAUSE OF DEATH AS CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XXL BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LOX BOSTON SCIENTIFIC NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death