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

Model Number	TRB29-LRG-01
Medical Device Problem Codes	Deflation Problem (1149); Gas/Air Leak (2946)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: mgr.The actual device has not 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 reported information: post cerebral angiogram, the tr band was stated to have 17 ml of air in band.In the pacu, the patient was complaining of pain above tr band site, therefore, the doctor looked at it and said it was muscular therefore it's more painful.The patient was given ice packs and norco to help with pain.At 1000, air was due to start coming out of tr band.When i started to take air out of the band, only 1 ml came out.They attempted to replace the syringe on the band; however, no more air came out.It was confirmed there was no air in the band, and the doctor was immediately notified.The band was taken off, and pressure was held for 10 minutes.Tr band was taken off and inflated to 17 ml to see if air would stay in the band.After 20 minutes, half of the air had deflated.Pressure was held from 1011 to 1035, then the doctor came out and assessed the site at 1035.He confirmed that the tr band had a leak in it.The doctor let the patient get up to go to the bathroom and he would be back to check the site after.A primapore was placed on the patient and she walked to the bathroom.The patient walked back to her bed without complications.The doctor came to bedside at 1112 and stated, "she's good to go home".The site was assessed again before she got dressed; site was free of hematoma and bleeding.The patient got dressed and was then discharged home.There was no blood loss.The device was not manipulated before use in any way - pre-use or during storage.
Additional Manufacturer Narrative
One tr band was returned for assessment.The sample was subjected to visual analysis.No damage or deformities were noted on the band or balloon assembly.There is 5.5ml 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, pieces of foreign matter were found.One tr band was returned for assessment and the sample leaked at the check valve due to foreign matter.The complaint can be confirmed for air leakage issues.The cause is 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; 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: 24778430
• Report Number: 1118880-2026-00085
• Device Sequence Number: 6134570
• Product Code: DXC
• UDI-Device Identifier: 00389701012476
• UDI-Public: (01)00389701012476(17)280301(10)0001287553
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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: TRB29-LRG-01
• Device Catalogue Number: TRB29-LRG-01
• Device Lot Number: 0001287553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• 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
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American