MAUDE Adverse Event Report: Terumo Medical Corporation ANGIO-SEAL; DEVICE, HEMOSTASIS, VASCULAR

Model Number	610130
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo received the following reported information: following a peripheral procedure, the doctor attempted to use the angio-seal by placing the bypass tube through the valve after locating the artery.Three devices were attempted; however, they did not function properly.However, a fourth device was used successfully.No blood loss was reported.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the complete investigation results.This reported event has been reassessed and deemed not reportable based upon the investigation of the actual sample.One (1) 6 french angio-seal device was returned for product evaluation.The returned sample included three locators, a hemostasis sheath, and the carrier tube.The device was visually inspected and found to have been in used condition with visible signs of blood.The carrier tube and sheath were returned separate.The components were attempted to be mated for functional testing.The sheath and carrier tube were able to be fully mated and set to forward lock and the anchor was able to be deployed from the sheath.No other damage or issues were noted.The angio-seal device was returned for evaluation.The sheath and carrier tube were able to be fully mated and set to forward lock position, deploying the anchor from the distal sheath tip.As a result, the complaint could not be confirmed for an assembly issue of the sheath and carrier tube.The exact root cause could not be determined.The device history record (dhr) 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 ; +1(949)989-0491
• MDR Report Key: 50408777
• Report Number: 3013394970-2026-00492
• Device Sequence Number: 18797029
• Product Code: MGB
• UDI-Device Identifier: 00389701011820
• UDI-Public: (01)00389701011820(17)270107(10)0001495427
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/24/2026

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 Model Number: 610130
• Device Catalogue Number: 610130
• Device Lot Number: 0001495427
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2026
• 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