BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOJET ULTRA 5000A

    MDR report key: 8636755 · Received May 23, 2019

    Report

    Report Number
    2134265-2019-05660
    Event Type
    Death
    Date Received
    May 23, 2019
    Date of Event
    April 24, 2019
    Report Date
    July 30, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    PMA / PMN Number
    P980037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT ANGIOJET ULTRA 5000A USED IN THE PROCEDURE EITHER HAD SERIAL # (B)(4)OR (B)(4). MODEL NUMBER: EITHER 45043 OR 45038. CATALOG NUMBER: EITHER 45043 OR 45038. SERIAL NUMBER: EITHER (B)(4) OR (B)(4). EXPIRATION DATE: EITHER 12/09/2031 OR 08/07/2025. UNIQUE IDENTIFIER (UDI) #: EITHER (B)(4) OR (B)(4). DEVICE MANUFACTURE DATE: EITHER 09/13/2018 OR 07/24/2015.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT ANGIOJET ULTRA 5000A USED IN THE PROCEDURE EITHER HAD SERIAL # (B)(4) OR (B)(4). MODEL NUMBER: EITHER 45043 OR 45038 CATALOG NUMBER: EITHER 45043 OR 45038 SERIAL NUMBER: EITHER (B)(4) OR (B)(4). EXPIRATION DATE: EITHER 12/09/2031 OR 08/07/2025 UNIQUE IDENTIFIER (UDI) #: EITHER (B)(4) OR (B)(4). DEVICE MANUFACTURE DATE: EITHER 09/13/2018 OR 07/24/2015. DEVICE EVALUATED BY MFR: THERE ARE TWO POSSIBLE ANGIOJET CONSOLES THAT COULD HAVE BEEN USED IN THIS PROCEDURE; SERIAL NUMBER (B)(4) OR (B)(4). NEITHER CONSOLE WAS RETURNED FOR EVALUATION. THE FIELD SERVICE ENGINEER (FSE) TESTED BOTH ANGIOJET CONSOLES AT THE SITE OF THE CUSTOMER. FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO FIND ANYTHING WRONG WITH THE ANGIOJET CONSOLES. THE SYSTEMS PASSED ALL FUNCTIONAL AND ELECTRICAL SAFETY TESTING WITHOUT ANY ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT DEATH OCCURRED. THE PATIENT EXPERIENCED CHEST PAIN AND LOSS OF CONSCIOUSNESS. AN ANGIOJET AVX CATHETER AND AN ANGIOJET CONSOLE WERE SELECTED FOR USE IN A DECLOT PROCEDURE IN THE LEFT ARM. DURING THE PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT SWINGS IN AND OUT OF CONSCIOUSNESS, WAS OUT OF BREATH AND FELT TIRED; HOWEVER THE PATIENT'S HEART RATE REMAINED STABLE. WHEN BEING DISCHARGED, THE PATIENT COMPLAINED OF HAVING TO BURP, BUT COULD NOT. THE PATIENT EXPERIENCED PAIN IN THE CHEST AND WAS TAKEN TO THE EMERGENCY ROOM WHERE THE PATIENT CODED AND DIED. IT WAS FURTHER REPORTED THAT THE CASE WAS FOR A GRAFT OR FISTULA IN A HEMODIALYSIS PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT DEATH OCCURRED. THE PATIENT EXPERIENCED CHEST PAIN AND LOSS OF CONSCIOUSNESS. AN ANGIOJET AVX CATHETER AND AN ANGIOJET CONSOLE WERE SELECTED FOR USE IN A DECLOT PROCEDURE IN THE LEFT ARM. DURING THE PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT SWINGS IN AND OUT OF CONSCIOUSNESS, WAS OUT OF BREATH AND FELT TIRED; HOWEVER THE PATIENT'S HEART RATE REMAINED STABLE. WHEN BEING DISCHARGED, THE PATIENT COMPLAINED OF HAVING TO BURP, BUT COULD NOT. THE PATIENT EXPERIENCED PAIN IN THE CHEST AND WAS TAKEN TO THE EMERGENCY ROOM WHERE THE PATIENT CODED AND DIED. IT WAS FURTHER REPORTED THAT THE CASE WAS FOR A GRAFT OR FISTULA IN A HEMODIALYSIS PATIENT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT ANGIOJET ULTRA 5000A USED IN THE PROCEDURE EITHER HAD SERIAL # (B)(4). MODEL NUMBER: EITHER 45043 OR 45038. CATALOG NUMBER: EITHER 45043 OR 45038. SERIAL NUMBER: EITHER (B)(4). EXPIRATION DATE: EITHER 12/09/2031 OR 08/07/2025. UNIQUE IDENTIFIER (UDI) #: EITHER (B)(4). DEVICE MANUFACTURE DATE: EITHER 09/13/2018 OR 07/24/2015.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT DEATH OCCURRED. THE PATIENT EXPERIENCED CHEST PAIN AND LOSS OF CONSCIOUSNESS. AN ANGIOJET AVX CATHETER AND AN ANGIOJET CONSOLE WERE SELECTED FOR USE IN A DECLOT PROCEDURE IN THE LEFT ARM. DURING THE PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT SWINGS IN AND OUT OF CONSCIOUSNESS, WAS OUT OF BREATH AND FELT TIRED; HOWEVER THE PATIENT'S HEART RATE REMAINED STABLE. WHEN BEING DISCHARGED, THE PATIENT COMPLAINED OF HAVING TO BURP, BUT COULD NOT. THE PATIENT EXPERIENCED PAIN IN THE CHEST AND WAS TAKEN TO THE EMERGENCY ROOM WHERE THE PATIENT CODED AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429646 ANGIOJET ULTRA 5000A CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death