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

Model Number	610131
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Diminished Pulse Pressure (2606)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following information: it was reported that upon deploying the 8fr angio-seal, the device failed causing the patient to get a cold leg and lose pulses.Angio from the other side showed the common femoral artery (cfa) was occluded where device was deployed.The physician stated that the vessel was quite calcified and likely not a great spot to use angio-seal, however, was his only option.Vessel was noticeable diseased.Attempts were made to balloon the angio-seal occlusion from the contralateral side and ultimately vascular surgery was performed to place a zilver stent in the common femoral artery (cfa).Extended manual pressure was used to control bleeding.The patient remained in stable condition.The estimated blood loss was less than 250cc.An 8fr procedure size sheath was used.This was a tough stick.No reported issues with insertion, deployment, or withdrawal of the device.A pre-deployment angiogram was performed, and it showed disease.Site was at or just below the common femoral artery bifurcation.Doplar gave initial concern.Angio eventually performed to show distal pulses were absent initially, however, fully restored following intervention.Surgical intervention was performed to treat the occlusion.Percutaneous transluminal angioplasty (pta) initially, ultimately stent rf.The procedure performed prior to the use of the angio-seal device was left heart catheterization (lhc)/percutaneous coronary intervention (pci).
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy.A2: age or date of birth: requested, not provided due to hospital policy.A3a: sex: requested, not provided due to hospital policy.A4: weight: requested, not provided due to hospital policy.A5: ethnicity: requested, not provided due to hospital policy.A6: race: requested, not provided due to hospital policy.D6b: explanted date: device was not explanted.E3: occupation: clinical operations coordinator.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)989-0491
• MDR Report Key: 50797583
• Report Number: 3013394970-2026-00558
• Device Sequence Number: 9525031
• Product Code: MGB
• UDI-Device Identifier: 00389701011813
• UDI-Public: (01)00389701011813(17)270306(10)0001600437
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/16/2026

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: 0001600437
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2026
• 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: Required Intervention; Other
• Patient Sex: Unknown