MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION TR BAND; CLAMP, VASCULAR

Model Number	TRB24-REG
Medical Device Problem Codes	Gas/Air Leak (2946); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation: ccl director the complaint cannot be confirmed for air flow issues as the sample was not returned for investigation.Without a sample, the exact root cause cannot be determined.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.
Event or Problem Description
Terumo medical corporation received the following reported information: following a right heart cath, the tr band was applied and 13ml's (11cc) of air was injected into the band.Forty-five (45) minutes later, the patient was moved from the operating room (or) to the holding area.When the nurse checked the tr band, they noticed the air was dissolved.A slow leak over time occurred.The balloon with 5cc of air leaked over a two (2) hour period.There was no noticeable damage to the device.The device was removed and replaced with new tr band and hemostasis was achieved.There was minimal blood loss, less than 5cc, and the patient was stable.

• Brand Name: TR BAND
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 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 ; 9499890491
• MDR Report Key: 24766348
• Report Number: 1118880-2026-00092
• Device Sequence Number: 10268385
• Product Code: DXC
• UDI-Device Identifier: 00389701011349
• UDI-Public: (01)00389701011349(17)280701(10)0001524360
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152525
• 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): 04/02/2026

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
• Device Catalogue Number: TRB24-REG
• Device Lot Number: 0001524360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO 5FR SLENDER SHEATH TERUMO RUN THROUGH WIRE
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 102 KG