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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the following information: it was reported that upon deployment, the angio-seal footplate did not properly deploy.When asked if all proper steps were taken, the doctorh stated that they were.The bypass tube was inserted into the sheath and advanced.They stated that the first click was done and a second click as well.When they went to pull back after the second click, the entire device came out of the patient.Once this happened, the team scrubbed in performed manual pressure to get hemostasis.The patient was reported to be ok as well.A 6fr sheath was used.No difficulties with access or any introductions through the sheath.A pre-deployment angiogram was performed.The estimated blood loss was greater than 250cc.The procedure performed prior to the use of the angio-seal was y-90.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy.A2: age & 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: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: interventional radiologist.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: 50246575
• Report Number: 3013394970-2026-00473
• Device Sequence Number: 18659589
• Product Code: MGB
• UDI-Device Identifier: 00389701011820
• UDI-Public: (01)00389701011820(17)260922(10)0001312583
• 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): N
• 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): 08/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2026
• Device Model Number: 610130
• Device Catalogue Number: 610130
• Device Lot Number: 0001312583
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown