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

Model Number	TRB29-LRG-01
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	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo received the following reported information: following a heart cath, the band was placed as normal, 12ml of air was injected into the band, and the patient was taken to post op.The nurse checked the band sixty (60) minutes after, and it was completely deflated.They proceeded to add 6ml in which the band deflated after a few minutes to one (1) ml.The location of the air leak was unknown.A new band was placed and had no issues.The patient had no blood loss or post op issues.It was also unknown whether there was any noticeable damage to the device or whether the device had been manipulated in any way before use or during storage.Prior to use, the product was stored under standard storage conditions.Medsun(b)(4): unplanned air loss in radial artery compression device (tr band-terumo) after cath procedure (supply defective- tr band would not hold air).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction to sections e4, g2, h10, attach the medsun, update section h3, and to provide the complete investigation results.One tr band and packaging label were returned for assessment.The sample was subjected to visual analysis.No damage or deformities were observed on the band or balloon assembly.There is 2.5ml of air left in the band.The sample was subjected to leak testing.Approximately 18ml of air was injected into the band and submerged in a water bath for 30 seconds.Air bubbles were observed from the check valve.The sample failed leak testing.The check valve was deconstructed to check for damage or foreign matter.Upon deconstruction, foreign matter was found.One tr band and packaging label were returned for assessment and the sample leaked at the check valve due to foreign matter.The complaint can be confirmed for foreign matter in the check valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with terumo medical corporation specifications and procedures.A corrective action was initiated for this issue.

• 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: 50546880
• Report Number: 1118880-2026-00624
• Device Sequence Number: 10311901
• Product Code: DXC
• UDI-Device Identifier: 00389701012476
• UDI-Public: (01)00389701012476(17)280701(10)0001520798
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2026

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: TRB29-LRG-01
• Device Catalogue Number: TRB29-LRG-01
• Device Lot Number: 0001520798
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Supplement Date Received by Manufacturer: 09/01/2026; 09/01/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/17/2026; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2026
• 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 Age: 71 YR
• Patient Sex: Male