BEUDAMED
    FDA Adverse Event Summary report: N

    TERUMO ANGIO-SEAL 6 FRENCH STS PLUS

    MDR report key: 16043407 · Received December 22, 2022

    Report

    Report Number
    MW5113973
    Date Received
    December 22, 2022
    Report Date
    December 16, 2022
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    MGB
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 1/3/2023 FOR REPORT MW5113973. I SUBMITTED A FORM 3500B REPORT OF A MEDICAL DEVICE DEFECT TO YOU WHICH YOU RECEIVED ON DECEMBER 5, 2022. IN THAT REPORT I STATED THAT I DID NOT KNOW WHETHER THE MANUFACTURER OF THE DEVICE INSERTED IN ME WAS ST. JUDE MEDICAL OR TERUMO MEDICAL CORPORATION AS THE MEDICAL RECORDS OF (B)(6) HOSPITAL STATED THAT IT WAS A ST. JUDE DEVICE, THOUGH THAT WAS DOUBTFUL. THE ATTORNEYS OF THE HOSPITAL HAVE NOW SENT ME THE ENCLOSED LETTER STATING THAT DESPITE THE CONTENT OF THE HOSPITAL MEDICAL RECORDS, IT WAS A TERUMO MEDICAL CORPORATION ANGIO-SEAL THAT WAS INSERTED IN ME AT THE END OF MY TAVR OPERATION. TERUMO AMERICAS HOLDING, INC. IS THE MANUFACTURER OF THE ANGIO-SEAL DEVICE, A SUBSIDIARY OF TERUMO CORPORATION OF JAPAN. WE ARE IN RECEIPT OF YOUR CORRESPONDENCE DATED NOVEMBER 30, 2022 DIRECTED TO DR. (B)(6)REQUESTING INFORMATION AS TO WHETHER A TERUMO VERSUS ST. JUDE ANGIOSEAL WAS UTILIZED DURING YOUR (B)(6) 2021 PROCEDURE. NOTWITHSTANDING THE DOCUMENTATION IN THE CHART, IT WAS A TERUMO ANGIOSEAL 6 FRENCH STS PLUS, LOT NUMBER 0000081589, PART NUMBER 17598 UTILIZED DURING YOUR PROCEDURE. UPON INFORMATION AND BELIEF, IT IS OUR UNDERSTANDING THAT THE EXPIRATION DATE FOR IT WAS AUGUST 31, 2022. THANK YOU.

    Description of Event or Problem · 0

    A TERUMO MEDICAL CORPORATION OR ST. JUDE MEDICAL ANGIO-SEAL DEVICE WAS INSERTED, ON (B)(6) 2021, IN MY LEFT GROIN AT THE END OF A TAVR PROCEDURE TO INSTALL A NEW AORTIC VALVE. ON THE FOLLOWING DAY, (B)(6) 2021, AFTER I WAS DISCHARGED FROM THE HOSPITAL, THE ANGIO-SEAL TOTALLY FAILED RESULTING IN MAJOR INTERNAL BLEEDING CAUSING MY THIGH TO MASSIVELY INCREASE IN SIZE THROUGH CREATION OF A 17 CM HEMATOMA THAT REQUIRED HOSPITAL READMISSION THE SAME DAY AND FIVE OPERATIONS TO CORRECT AND CLEAN OUT THE HEMATOMA. ALSO ATTACHED IS A PICTURE OF THE TERUMO ANGIO-SEAL DEVICE, A COPY OF THE (B)(6) ANGIO­ SEAL WAS INSERTED IN ME AND NOT A TERUMO DEVICE, AND HOSPITAL RECORDS CONCERNING MY FIVE OPERATIONS RESULTING FROM THE HUMONGOUS HEMATOMA AND MAJOR BLOOD LOSS. I DO NOT KNOW IF THE HOSPITAL RECORD WAS CORRECT, AND IT COULD HAVE BEEN A FIVE YEAR OLD ST. JUDE DEVICE OR A MORE RECENT TERUMO DEVICE. ST. JUDE-ABBOTT LABORATORIES SOLD THEIR ANGIO-SEAL BUSINESS AND PATENTS TO TERUMO IN (B)(6) 2017. THE ANGIO-SEAL WAS EITHER A ST. JUDE MEDICAL SCI DAIG ANGIO-SEAL OR A TERUMO ANGIO-SEAL, AS THE MEDICAL RECORDS FROM THE HOSPITAL STATED THAT THE ANGIOSEAL WAS A (B)(6), BUT ST. JUDE MEDICAL (ABBOTT LABORATORIES) TOLD ME THEY SOLD THEIR ANGIOSEAL BUSINESS AND THE PATENTS TO TERUMO MEDICAL CORPORATION IN (B)(6) 2017 WHICH IS NOW KNOWN AS (B)(6). TERUMO IS A SUBSIDIARY OF TERUMO CORPORATION OF JAPAN. I HAVE ASKED THE ATTORNEYS FOR THE HOSPITAL AND THE DOCTORS IF THE ANGIOSEAL INSERTED IN ME WAS A FIVE YEAR OLD ST. JUDE ANGIOSEAL OR A MORE RECENT TERUMO ANGIOSEAL. BUT NEITHER THEIR ATTORNEYS OR DOCTORS WOULD ANSWER THE QUESTION. THEREFORE I DO NOT KNOW IF THE FAILED ANGIO-SEAL WAS AN OLD ST. JUDE ANGIOSEAL OR A MORE RECENT TERUMO ANGIOSEAL. IN ANY EVENT IT TOTALLY FAILED CAUSING ME GREAT PAIN AND SUFFERING AND FIVE OPERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261463 TERUMO ANGIO-SEAL 6 FRENCH STS PLUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORP. 610130 081589

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male ALLOPURINOL | B12| BUMETANIDE| COUMADIN| CYMBALTA| ENTRESTO| FERROUS SULFATE| JARDIANCE| MAGNESIUM| MECHANICAL MITRAL VALVE| METOPROLOL | PACEMAKER| REPAIRED TRICUSPID VALVE | REPLACED AORTIC VALVE | ROSUVASTATIN | VITAMIN C