MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION ANGIO-SEAL; DEVICE, HEMOSTASIS, VASCULAR

Model Number	610131
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: value analysis coordinator.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.
Event or Problem Description
Terumo medical corporation received the following reported information: following a carotid stent via 8 french sheath, the angio-seal was attempted to close the left groin.However, the device did not achieve homeostasis at withdrawal.Therefore, manual pressure was applied was a femstop was used.The staff transferred the patient was the procedure table to a stretcher while holding pressure.A staff member held manual pressure and needed to be switched out multiple times.The patient was wheeled out to post-op while staff member held pressure.Hemostasis should have been achieved prior to moving the patient.The patient was stable, and the blood loss was less than 250cc.A pre-deployment angiogram was performed.There were no difficulties with arterial access, sheath, guidewire, or catheter insertion.No equipment or other devices were used with the angio-seal.The patient was on heprin, plavix, brilinta; however, did not have a history of a bleeding disorder.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for deployment difficulties as the sample was not returned for investigation.Without a sample, the exact root cause cannot be determined.The device history record review determined that the device was in a conforming state when released from terumo control.There is no indication that any manufacturing, design, or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea)/hazard based risk table (hbrt).

• 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
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 24619052
• Report Number: 3013394970-2026-00101
• Device Sequence Number: 9834274
• Product Code: MGB
• UDI-Device Identifier: 00389701011813
• UDI-Public: (01)00389701011813(17)260821(10)0001226213
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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 Expiration Date: 08/21/2026
• Device Model Number: 610131
• Device Catalogue Number: 610131
• Device Lot Number: 0001226213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 122 KG