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

Model Number	610131
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: inventory.One (1) 8 french angio-seal vip device was returned for product evaluation.The returned sample includes the carrier tube.The device was subjected to visual analysis.The device appears to be in used condition with visible signs of blood.The carrier tube is in forward lock position.The bypass tube is detached from the carrier tube.The returned sample included the carrier tube in forward lock position, with the bypass tube detached.The complaint description and additional information provided by the reporter alleges a pullout of the device occurred, and the carrier tube was separated from the sheath prior to return.Therefore, the complaint can be confirmed for a device pullout.The exact root cause cannot be determined.The likely cause is the hemostasis sheath and carrier tube were not properly mated, leading to the observed pullout.This is indicated by the carrier tube being in forward lock position.The device history record review determined the device was in a conforming state when released from terumo control.There are no indications manufacturing issues may have led to this event.No action is recommended since this risk evaluation is within the predetermined limits.Tmc initiated a capa for the timeliness of the mdr.
Event or Problem Description
Terumo medical corporation received the following reported information: the type of procedure performed was sma aneurysm embolization/ bilateral common iliac stenting from femoral approach via 7 french pinnacle sheath.The device did not seal.There were no difficulties with arterial access, sheath, guidewire, or catheter insertion noted by the doctor.There was a pre-deployment angiogram performed.The doctor believed everything went smooth.He said when he pulled back, he did not think the ankur engaged and everything came out.He said he could see the anchor in the device still.Hemostasis was achieved by manual pressure.The doctor estimated the blood loss was 10 cc.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 PUERTO RICO LLC; 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: 24982360
• Report Number: 3013394970-2026-00234
• Device Sequence Number: 9698917
• Product Code: MGB
• UDI-Device Identifier: 00389701011813
• UDI-Public: (01)00389701011813(17)261016(10)0001354619
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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: 610131
• Device Catalogue Number: 610131
• Device Lot Number: 0001354619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• 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 Age: 67 YR
• Patient Sex: Male