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

Model Number	610130
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical corporation received the following information: it was reported that the angio-seal was being used on the patient.When they got to the pull back step and whole angio-seal pulled out of the patient.The anchor never came out of the tip of the sheath.Manual pressure was applied.The patient was ok.The doctor cut open the sheath to visualize, the anchor was stuck in the sheath.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e3: occupation: (b)(6).The actual device has not been 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: 50882882
• Report Number: 3013394970-2026-00578
• Device Sequence Number: 10704765
• Product Code: MGB
• UDI-Device Identifier: 00389701011820
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 0001617858
• Was Device Available for Evaluation?: Yes
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2026
• 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: 79 YR
• Patient Sex: Male