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

Model Number	610130
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
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: not provided due to hospital policy.A6: race: not provided due to hospital policy.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: lead tech.One (1) 6 french angio-seal device was returned for product evaluation.The returned device included arteriotomy locator, hemostasis sheath, carrier tube, and packaging.The device was visually inspected and found to have been in used condition with visible signs of blood.The sheath and locator assembly was found fully mated and kinked at the blood inlet holes.No other damage or issues were identified.The sheath and locator assembly was found fully mated and kinked at the blood inlet holes.The complaint was able to be confirmed for a kinked sheath and locator assembly.The exact root cause was unable to be determined.The likely cause was determined to have been damage sustained by the device during attempted insertion into the patient.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)/failure mode and effects analysis (fmea).
Event or Problem Description
Terumo received the following reported information: the 6 french angio-seal sheath and dilator could not enter into the common femoral artery (cfa).A 6 french sheath was used for the intervention.The anatomy was not tortuous, larger than 5mm cfa, and no calcium.A perclose was used after attempted use of the angio-seal and nothing worked.The patient ended up having a pseudoaneurysm; however, the patient left unharmed.The estimated blood loss was less than 250cc.There were not any difficulties with arterial access, sheath, guidewire, or catheter insertion.There was a pre-deployment angiogram performed.There were not any issues with insertion, deployment, or withdrawal of the device.Since the perclose did not work manual pressure was held.The patient was stable.

• 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 MEDICAL CORPOTATION; innovacion street lot 21; caguas west industrial park; caguas 00725 ; * 00725
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 25509162
• Report Number: 3013394970-2026-00364
• Device Sequence Number: 16078606
• Product Code: MGB
• UDI-Device Identifier: 00389701011820
• UDI-Public: (01)00389701011820(17)270121(10)0001520861
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 06/15/2026

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: 0001520861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2026
• 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