BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 2904921 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08357
    Event Type
    Death
    Date Received
    January 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR. THE UNIT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. THE MOTOR DRIVE UNIT MEETS SPECIFICATIONS OF THE FUNCTIONAL TEST. THE UNIT SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN FOR 5 HRS. THE MOTOR TORQUE TEST PASSED THE SPECIFICATIONS. THE PROBLEM COULD NOT BE REPRODUCED AS INDICATED IN THE ORIGINAL COMPLAINT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2012-08356. IT WAS REPORTED THAT DURING CORONARY LEFT ANTERIOR DESCENDING (LAD) TREATMENT PROCEDURE, A PATIENT DEATH OCCURRED. THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION (MI). THE PHYSICIAN WENT IN WITH F/G, ATLANTIS, SR PRO CATHETER AFTER NON-BSC STENTING. A MOTOR DRIVE UNIT (MDU) OVERLOAD MESSAGE OCCURRED ON THE ILAB SYSTEM. THE PHYSICIAN WALKED AWAY TO TROUBLE SHOOT THE ISSUE WHILE THE CATHETER WAS IN POSITION. THROMBOSIS "CLOTTED OFF" THE LAD DURING THE PROCEDURE. THE CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED WITH THE CATHETER STILL IN THE PATIENT. THE CATHETER WAS REMOVED AND THE PATIENT EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE VESSEL WAS VERY CALCIFIED. THE DOCUMENTED CAUSE OF DEATH WAS THROMBOSIS. THE PHYSICIAN BELIEVES THAT THE PATIENT WAS RESISTANT TO THE ANTI THROMBOLITICS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE VESSEL WAS VERY CALCIFIED. THE DOCUMENTED CAUSE OF DEATH WAS THROMBOSIS. THE PHYSICIAN BELIEVES THAT THE PATIENT WAS RESISTANT TO THE ANTI THROMBOLYTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11359 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB120CART0

    Patients

    Seq Age Sex Outcome Treatment
    1 Death XIENCE-STENT| ATLANTIS SR PRO