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	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided, a2: age & date of birth: requested, not provided, a3a: sex: 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, e1: last name: requested, unknown, e3: occupation: requested, unknown.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.
Event or Problem Description
Terumo medical corporation received the following information: it was reported that the angio-seal device did not appear to have a suture or collagen in it.There was no blood loss.
Additional Manufacturer Narrative
This report is being sent 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 as the sample was not returned for investigation.Without the 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 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: 24860691
• Report Number: 3013394970-2026-00198
• Device Sequence Number: 9271196
• Product Code: MGB
• UDI-Device Identifier: 00389701011813
• UDI-Public: (01)00389701011813(17)260730(10)0001205703
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: 07/30/2026
• Device Model Number: 610131
• Device Catalogue Number: 610131
• Device Lot Number: 0001205703
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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 Sex: Unknown