MAUDE Adverse Event Report: Terumo Medical Corporation (TMC) TR BAND; CLAMP, VASCULAR

Model Number	TRB24-REG-01
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo received the following reported information: the patient was transferred from one hospital to another with the tr band in place.The band had been titrated several times and the patient remained stable.The registered nurse (rn) had initiated the deflation process by removing 2 ml of air three times.About halfway through the titration process (two hours after inflation), staff noticed that the inflation mechanism appeared to be leaking.Due to the leak, the tr band was removed, manual pressure was applied for approximately thirty (30) minutes, and a dressing was applied.Before the next deflation, the laboratory staff entered the room to draw blood and immediately returned to alert the team that the patient was bleeding from the radial access site.The patient experienced minor to moderate blood loss at the access site (less than 250cc), and small to moderate-sized hematoma.They attribute the minor blood loss to how frequently they performed assessments; therefore, they noticed the leak promptly.The patient remained stable, with no issues noted with heart rate or blood pressure.A 6 french terumo radial sheath was used for vascular access.There was no obvious or noticeable damage to the device.The product was not manipulated in any way prior to use or during storage and had been stored in a cupboard prior to use.The procedure performed was an angiogram.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: phone number: (b)(6).E3: occupation: clinical nurse educator.The actual device was not available; therefore, the actual device will not be returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.

• Brand Name: TR BAND
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): Terumo Medical Corporation (TMC); 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): Terumo Medical Corporation; 950 elkton blvd; elkton MD 21921
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; +1(949)989-0491
• MDR Report Key: 50691617
• Report Number: 1118880-2026-00633
• Device Sequence Number: 9614220
• Product Code: DXC
• UDI-Device Identifier: 00389701012469
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K213531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: TRB24-REG-01
• Device Catalogue Number: TRB24-REG-01
• Device Lot Number: 0001598023
• Was Device Available for Evaluation?: No
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2026
• 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