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

Model Number	610130
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo received the following reported information: following a left heart cath via 6 french sheath, the angio-seal did not deploy.No blood loss was reported.There were no reported difficulties with arterial access, sheath placement, guidewire advancement, or catheter insertion.A pre-deployment angiogram was performed.There were no reported issues with insertion, deployment, or withdrawal of the device.Hemostasis was achieved using manual pressure.The patient was stable.No concomitant medical products were used with the angio-seal.
Additional Manufacturer Narrative
A5: ethnicity: not provided due to hospital policy.A6: race: not provided due to hospital policy.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: tm.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: 50883743
• Report Number: 3013394970-2026-00554
• Device Sequence Number: 9791903
• Product Code: MGB
• UDI-Device Identifier: 00389701011820
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 610130
• Device Catalogue Number: 610130
• Device Lot Number: 0001614046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2026
• 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 Sex: Unknown