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

Model Number	610131
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
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.D6a: implanted date: unknown if the device was implanted.D6b: explanted date: unknown if the device was explanted.E3: occupation: ir lab manager.The actual device has 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 during the closure of an 8fr femoral access procedure the 8fr angio-seal had an issue during deployment and may not have made a full second click during deployment.The procedure prior to the use of the angio-seal device was femoral access neurovascular procedure.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update sections d4, h3 and h4 and to provide the completed investigation results.One (1) 8fr angioseal device was returned to terumo medical corporation for product evaluation.The returned sample included the carrier tube, hemostasis sheath, locator, and guidewire.The device was visually inspected and found to have been in used condition with visible signs of blood.The carrier tube and hemostasis sheath were returned fully mated and fully rear locked.The suture and tamper tube were also returned.The suture was cut at the distal tip and appeared torn at the proximal end.The carrier tube hub was opened, and the suture was found to have been torn.The carrier tube and hemostasis sheath were returned fully mated and fully rear locked.The suture was cut at the distal tip and appeared torn at the proximal end.The carrier tube hub was opened, and the suture was found to have been torn.The suture certificate of analysis was subsequently requested from the manufacturing facility and reviewed to ensure compliance with device standards.The component was within the appropriate specifications at the time of manufacturing.The component may have broken due to excessive force during use.The cause of the event could not be determined based on the available information.As a result, the complaint was confirmed.The exact root cause cannot be determined.Review of device history record (dhr) showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.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: 24537009
• Report Number: 3013394970-2026-00106
• Device Sequence Number: 9027096
• Product Code: MGB
• UDI-Device Identifier: 00389701011813
• UDI-Public: (01)00389701011813(17)260923(10)0001312599
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 09/23/2026
• Device Model Number: 610131
• Device Catalogue Number: 610131
• Device Lot Number: 0001312599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• 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