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

Model Number	610131
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received an fda medwatch report # mw5189889.The event description states: "right groin hematoma after patient attempted bowel movement (and after working with ot) on (b)(6) 2026.Hematoma was about 8' diameter and bubbled up.Manual pressure applied for 45 min.Manual pressure held additional 2 x 20 min for re-occurring right groin hematoma.Total 85 min pressure held.No recurrence since.Angioseal originally placed on (b)(6) 2026.No external oozing or bleeding, all internal.Diagnosis for use: obesity." additional information was received on 21jul2026: procedure performed was a bilateral middle meningeal artery embolization.An 8f procedure sheath was used.No complications with arterial access, sheath, guidewire, or catheter insertion.No issues with insertion, deployment, or withdrawal.A pre-deployment angiogram was performed.Patient was stable.Blood loss was less than 250cc.
Additional Manufacturer Narrative
D6b: explanted date: device was not explanted.The actual device is not available for return.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)980-9491
• MDR Report Key: 50224292
• Report Number: 3013394970-2026-00477
• Device Sequence Number: 16036563
• Product Code: MGB
• UDI-Device Identifier: 00389701011813
• UDI-Public: (01)00389701011813(17)270121(10)0001520690
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2026

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: 610131
• Device Catalogue Number: 610131
• Device Lot Number: 0001520690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2026
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 147 LB
• Patient Race: White