BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOJET ULTRA 5000A

    MDR report key: 8636727 · Received May 23, 2019

    Report

    Report Number
    2134265-2019-05656
    Event Type
    Injury
    Date Received
    May 23, 2019
    Date of Event
    April 26, 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). 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) #: (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). D4: MODEL NUMBER: EITHER 45043 OR 45038. D4: CATALOG NUMBER: EITHER 45043 OR 45038. D4: SERIAL NUMBER: EITHER (B)(6). D4: EXPIRATION DATE: EITHER 12/09/2031 OR 08/07/2025. D4: UNIQUE IDENTIFIER (UDI) #: EITHER (B)(6). H4: 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 U5050 OR U2843. 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 THAT THE PATIENT EXPERIENCED BRADYCARDIA AND VENTRICULAR TACHYCARDIA DURING THE PROCEDURE. 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'S HEART RATE WAS IN THE 80'S THEN IT DROPPED TO THE 30'S. THERE WAS A SIGNIFICANT AMOUNT OF PAIN IN THE CHEST/LUNGS AND THE PROCEDURE HAD TO BE STOPPED. ALMOST IMMEDIATELY AFTER THE USE OF THE ANGIOJET, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA. AFTER THE PROCEDURE, THE PATIENT FELT THE NEED TO VOMIT. 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 THAT THE PATIENT EXPERIENCED BRADYCARDIA AND VENTRICULAR TACHYCARDIA DURING THE PROCEDURE. 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'S HEART RATE WAS IN THE 80'S THEN IT DROPPED TO THE 30'S. THERE WAS A SIGNIFICANT AMOUNT OF PAIN IN THE CHEST/LUNGS AND THE PROCEDURE HAD TO BE STOPPED. ALMOST IMMEDIATELY AFTER THE USE OF THE ANGIOJET, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA. AFTER THE PROCEDURE, THE PATIENT FELT THE NEED TO VOMIT. 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 THAT THE PATIENT EXPERIENCED BRADYCARDIA AND VENTRICULAR TACHYCARDIA DURING THE PROCEDURE. 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'S HEART RATE WAS IN THE 80'S THEN IT DROPPED TO THE 30'S. THERE WAS A SIGNIFICANT AMOUNT OF PAIN IN THE CHEST/LUNGS AND THE PROCEDURE HAD TO BE STOPPED. ALMOST IMMEDIATELY AFTER THE USE OF THE ANGIOJET, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA. AFTER THE PROCEDURE, THE PATIENT FELT THE NEED TO VOMIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429096 ANGIOJET ULTRA 5000A CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other