MAUDE Adverse Event Report: Terumo Medical Corporation ANGIO-SEAL; DEVICE, HEMOSTASIS, VASCULAR

Model Number	610130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Swelling/ Edema (4577)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following information: it was reported that an angio-seal device was used on the patient and had to be hospitalized later with a grapefruit size hematoma and potentially a pseudoaneurysm.The procedure and angio-seal insertion occurred on (b)(6), 2026.On (b)(6), 2026, the patient was transported to the hospital after walking and feeling a pop at the access site, followed by severe pain and swelling approximately the size of a grapefruit.The patient was admitted for application of a pressure dressing and consultation with vascular surgery.Prior to closure with the angio-seal device, the patient underwent a prostatic artery embolization (pae) procedure.No difficulties were noted with arterial access, sheath placement, guidewire, or catheter insertion in the operative note.A pre-deployment angiogram was not confirmed.Computed tomography (ct) images from the pae procedure.No difficulties were documented in the operative note regarding insertion, deployment, or withdrawal of the device.The patient was hospitalized overnight and required a pressure bandage and vascular surgery consultation.At this time, no further surgical intervention is required.The estimated blood loss was less than 250ml.The patient was admitted on (b)(6), 2026, and discharged the following day, (b)(6), 2026, in stable condition.During the post-operative call on (b)(6), 2026, the patient reported tenderness, moderate swelling, and bruising at the access site.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided d6b: explanted date: the device was not explanted e3: occupation: ir nurse manager 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.

• Brand Name: ANGIO-SEAL
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): Terumo Medical Corporation; 265 davidson ave; suite 320; somerset NJ 08873
• Manufacturer (Section G): Terumo Puerto Rico LLC; innovacion street lot 21; caguas west industrial park; caguas, 00725 ; PR 00725
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; +1(949)989-0491
• MDR Report Key: 50716634
• Report Number: 3013394970-2026-00538
• Device Sequence Number: 10066100
• Product Code: MGB
• UDI-Device Identifier: 00389701011820
• UDI-Public: (01)00389701011820(17)270320(10)0001602877
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 610130
• Device Catalogue Number: 610130
• Device Lot Number: 0001602877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 171 LB
• Patient Race: White