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

Model Number	TRB24-REG
Medical Device Problem Codes	Deflation Problem (1149); Gas/Air Leak (2946)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation: tech.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
Terumo medical corporation received the following information: it was reported that original a tr band was applied post radial procedure.A hematoma developed proximal to the band after a couple of minutes.Manual pressure was applied and then the tr band was repositioned.It was noted at that point that the tr band appeared to be losing air.More air was added, however, again there was a slow leak.A new tr band was placed on the patient and there were no further complications.Hemostasis was achieved using the second tr band that was applied.The first tr band initially had 15ml of air, however, during repositioning, it was noticed that only 12ml was able to be removed.15ml was added for the repositioning and then when air was leaking again, a new tr band was applied with 11ml of final air volume (which held just fine).The tr band started to deflate within a few minutes, once it was determined that they wanted to reposition the band.They suspected the leak was coming from the "pillow" however, they were unable to confirm exactly where.The size of the hematoma was about the size of a half dollar coin.The patient remained in stable condition.The second tr band that was applied worked great and the md evaluated the hematoma.The device did not have noticeable damage.The estimated blood loss was less than 250cc.The procedure performed prior to the use of the tr band was r2p intervention.

• 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: 24917532
• Report Number: 1118880-2026-00147
• Device Sequence Number: 10330666
• Product Code: DXC
• UDI-Device Identifier: 00389701011349
• UDI-Public: (01)00389701011349(17)280401(10)0001343316
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 0001343316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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: R2P DESTINATION SLENDER 119CM SHEATH
• Patient Sex: Unknown