BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US

    MDR report key: 15646077 · Received October 21, 2022

    Report

    Report Number
    3013394970-2022-00309
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    August 14, 2022
    Report Date
    October 21, 2022
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00389701011820
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXPLANTED DATE: IT IS UNKNOWN IF THE DEVICE WAS EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH NO FINDINGS. THE ACTUAL DEVICE WAS NOT AVAILABLE; THEREFORE, THE ACTUAL DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. # 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE COMPLAINT CANNOT BE CONFIRMED FOR THE ALLEGED ALLEGATION. BASED ON THE INFORMATION GIVEN, THE EXACT ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. WITH LOT OF KEY DETAILS REGARDING THE CASE NOT AVAILABLE, NO CONCLUSIONS CAN BE MADE. THE DEVICE WAS IN A CONFORMING STATE WHEN RELEASED FROM TERUMO CONTROL. THERE IS NO INDICATION THAT ANY MANUFACTURING ISSUES MAY HAVE LED TO THIS EVENT. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE FAILURE MODE & EFFECTS ANALYSIS (FMEA).

    Description of Event or Problem · 0

    TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5111829. THE EVENT DESCRIPTION STATES: "PMA APPROVED "ANGIO SEAL" VIP VASCULAR CLOSURE IMPLANT. MANUFACTURERS ACCT# (B)(4), REF#610130, LOT#0000209600. HX# (B)(4)?" I DISCOVERED (B)(6) 2022 AT THE (B)(6) HOSPITAL ER THAT ON (B)(6) 2022 AND (B)(6) 2022 I MOST LIKELY HAD A LIGHT HEART ATTACK (B)(6) 2022 AND MODERATE ON (B)(6) 2022 WHICH BROUGHT ME IN. THEY MOVED ME TO OPERATING ROOM FOR A HEART CATH. FOR THE CATH THE CARDIO SURGEON ENTERED NEAR MY RIGHT GROIN INTO MY RIGHT FEMORAL ARTERY. HE PIERCED OPEN THE ARTERY, TRAVELED HIS EQUIPMENT UPWARD TO THE HEART. HE FOUND A 99% BLOCKAGE OF MY RIGHT CORONARY ARTERY. HE REPAIRED BY ANGIOPLASTY, THEN STENT. HE BACKED UP HIS EQUIPMENT THROUGH THE ENTRY/EXIT POINT MADE TO THE ARTERY. HE PLACED THE DEVICE IN QUESTION "ANGIO-SEAL" (YOUR PMA APPROVED PRODUCT) TO CLOSE MY FEMORAL ARTERY. HE THEN CLOSED UP THE OUTER SKIN ENTRY/EXIT POINT. I NOW WORK FOR THE (B)(6) PUBLIC ELEMENTARY SCHOOL DURING THE NORMAL SCHOOL YEAR. I AM WORKING FULL TIME SCHOOL YEARS WITH ECSE-SPECIAL EDUCATION EARLY CHILDHOOD INTERVENTION. I CONSIDER THIS A CHANCE TO EXPAND, AND LEAVE A POSITIVE INFLUENCE BEHIND. I HAVE NOT BEEN ABLE TO REPORT FOR DUTY THIS SCHOOL YEAR YET DUE TO RECOVERY AND RESTRICTIONS." ON (B)(6) 2022, AFTER A NOON-ISH DISCHARGE, AT HOME, I NOTICED A (SAME DAY) SWELLING (HEMATOMA) NEAR MY GROIN FILLING QUICKLY. I REASONED IT WAS AN ARTERY BLEED RELATED TO MY HEART CATHETER PROCEDURE. SINCE FEMORAL ARTERY BLEEDS COULD LEAD TO BLEED OUT DEATH I SHOWED MY HEMATOMA TO MY SPOUSE AND EXPLAINED. MY WIFE ONCE AGAIN, SAME DAY AS DISCHARGE, RACED ME BACK TO THE (B)(6) ER. ONCE AT ER I EXPLAINED I THOUGHT I WAS HAVING UNCONTROLLED FEMORAL ARTERY BLEED, POSSIBLY BLEED OUT, DEPENDING ON TIME TO TREATMENT. I FELT IT WAS RELATED TO THAT EARLIER CATHETER PROCESS, AND COULDN'T CONTROL IT. THEY PREPPED ME, VIEWED THE AREA, MANIPULATED THE HEMATOMA, SAND BAGGED ME, RAN TESTS AND IMAGING, THEN CALLED THE CARDIO VASCULAR SURGEON. ONCE IN THE OR WHERE I WAS PLACED UNDER GENERAL ANESTHESIA. THE SURGEON SLICED ME OPEN ABOVE THE GROIN, SKIN, CLOSURE POINT. FOUND, AND SUTURED CLOSED THE ACTIVE FEMORAL ARTERY EXIT POINT BLEED. YOUR APPROVED "ANGIO-SEAL" DEVICE COULDN'T BE LOCATED. THE FEMORAL ARTERY BLEED WAS CLOSED, AND I WAS MOVED TO RECOVERY AS AN IN PATIENT. STILL (B)(6), THE DAY YOUR APPROVED "ANGIO-SEAL" DEVICE HAD ORIGINALLY CLOSED THE FEMORAL ARTERY IN MY RIGHT GROIN AREA. LATER DURING MY INPATIENT STAY THE TOP OF MY RIGHT KNEE WENT NUMB, THE RIGHT GROIN HEMATOMA, AND RIGHT GROIN FEMORAL ARTERY BOUNCED FROM MODERATE PAIN TO EXCRUCIATING PAIN ALL THE WAY TOWARDS MY RIGHT KNEE. I WAS BARELY ABLE TO GET OUT OF BED TO TOILET EVEN ON MY BEST DAYS. I HAD TO TAKE ASSORTED PRESCRIPTION PAINKILLERS. THIS WAS UNQUESTIONABLY SEVERAL LEVELS WORSE THAN MY STENT PLACEMENT AND CLOSURE WITH "ANGIO SEAL". I AM HOME RECOVERING. HIP TO KNEE PAIN. 2ND HEMATOMA APPEARED AND WAS DIAGNOSED AS LYMPHATIC FLUID AND BLOOD SURFACING FROM THE ORIGINAL INTERNAL OPEN FEMORAL BLEED. I TOLD THE CARDIO AND VASCULAR SURGEONS ON FOLLOW UP APPOINTMENTS THAT I REASONED THE OPEN FEMORAL BLEED WAS DUE TO THE ANGIO SEAL LETTING GO, AND TRAVELING AWAY. THEREBY A DEVICE FAILURE. THEY ALL VERBALLY AGREED WITH ME AND FURTHER STATED THAT IT FAILS IN SOME WAY TIME TO TIME. WHAT DO YOU (FDA) DO FOR US STATISTICAL RISK ACCEPTED EXCEPTIONS WHEN YOUR PMA APPROVAL WORKS AGAINST US? I UNDERSTAND THIS DEVICE IS LIKELY TO CAUSE FURTHER PROBLEMS AS THE COLLAGEN PLUG PROMOTES CLOTTING WHEREVER ELSE IT'S NO LODGED. TERUMO INTERVENTIONAL SYSTEMS. FDA SAFETY REPORT ID# (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558695 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 0000209600 00389701011820

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other