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	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation: peri coordinator the actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.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.Review of the device history record (dhr) showed there were no issues noted during the manufacturing of the product that could have contributed to this complaint condition.No action is recommended since this risk evaluation is within the predetermined limits.
Event or Problem Description
Terumo medical corporation received the following information: it was reported that the tr band did not hold air, they finished with a new tr band.Approximately 15ml of air was injected when the tr band was applied, however it would not maintain air at the beginning of the procedure.A glideslender sheath was used at the access site.The estimated blood loss was less than 250cc.The patient remained stable and there was no patient harm.The procedure performed prior to the use of the tr band was a percutaneous coronary intervention (pci).There was not any noticeable damage to the device.It is unknown how hemostasis was achieved.

• 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: 24865738
• Report Number: 1118880-2026-00133
• Device Sequence Number: 10476164
• Product Code: DXC
• UDI-Device Identifier: 00389701011349
• UDI-Public: (01)00389701011349(17)280601(10)0001472622
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 0001472622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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: GLIDESHEATH SLENDER SHEATH
• Patient Sex: Unknown