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

Model Number	610131
Medical Device Problem Codes	Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical corporation received the following information: it was reported that when deploying the angio-seal the doctor could not pull back on the device after deploying the footplate.Doctor cut the carrier tube and pulled the sheath off exposing the suture.She then pulled back on the suture and tamped with the tamper, finished the deployment with no other issues.A 7fr.Procedure sheath was used.A pre-deployment angiogram was performed.There were no issues or difficulties with arterial access, sheath, guidewire, or catheter insertion.There patient had a peripheral procedure.There was no blood loss.
Additional Manufacturer Narrative
D6b: explanted date: device was not explanted.E3: occupation: vascular surgeon.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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.One (1) 8fr angio-seal device was returned to terumo medical corporation for product evaluation.The returned device included the header bag, arteriotomy locator, hemostasis sheath, and carrier tube.The device was visually inspected and found to have been in used condition.The sheath and carrier tube were returned fully mated and in rear lock position.The shaft of the carrier tube was noted to be cut near the base and was separate from the assembly.The tamper tube was also separate from the assembly.Functional testing was performed by disassembling the device and isolating the suture spool and attempting to deploy the suture.The suture was able to be deployed without issue.The angio-seal device was returned fully rear locked with the shaft of the carrier tube cut from the device.The internal components were deployed and were not returned with the device.The suture spool was inspected and the component was undeployed.Functional testing was performed, and the suture was able to be fully deployed.The cause of the event could not be identified based on the available information.It is possible that the user did not apply sufficient force to deploy the component.As a result, the complaint was confirmed for suture withdrawal difficulty.The exact root cause cannot be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with terumo medical corporation specifications and procedures and the device was released in a conforming state.Currently, no action is recommended since the 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: 24698907
• Report Number: 3013394970-2026-00131
• Device Sequence Number: 10176918
• Product Code: MGB
• UDI-Device Identifier: 00389701011813
• UDI-Public: (01)00389701011813(17)260305(10)000102726
• 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
• Device Implanted Year: 2026
• 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): 03/26/2026

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: 03/05/2026
• Device Model Number: 610131
• Device Catalogue Number: 610131
• Device Lot Number: 0001021726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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