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

Model Number	TRB29-LRG-01
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that upon completing a cardiac catheterization the tr band was placed on the patient and the sheath was removed per protocol.The tr band did not hold pressure, so the band was removed and replaced with another tr band with the same lot number and the new tr band performed as intended.There was no blood loss.Additional information was received on 21jul2025: 18ml's of air were injected into the tr band when it was applied.The tr band started to deflate immediately.The patient was stable.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.Based on the evaluation of the returned sample this report is now deemed not reportable.One tr band, inflator, and packaging were returned to terumo medical corporation for assessment.The sample was subjected to visual analysis.No damage or deformities were noted on the band or inflator.There is 4 ml of air left in the band.The sample was subjected to leak testing.Approximately 18 ml of air was injected into the band and submerged in a water bath for 30 seconds.Air bubbles were observed from the balloon tab.The sample failed leak testing.The sample was subjected to microscopic inspection.Upon microscopic analysis, there is a crack in the connection tube at the v notch.One tr band, inflator, and packaging were returned for assessment, and no damage or deformities were noted on the band or inflator.The sample was subjected to leak testing and leaked at the balloon tab due to a crack in the connection tube at the v notch.The complaint can be confirmed for air leakage issues.The cause is a crack in the connection tube at the v notch.A nonconformance was initiated for this issue.Review of the device history record (dhr) showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.Currently, no action is recommended since the risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).

• 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: 22801385
• Report Number: 1118880-2025-00111
• Device Sequence Number: 7798608
• Product Code: DXC
• UDI-Device Identifier: 00389701012476
• UDI-Public: (01)00389701012476(17)270601(10)0000809097
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 0000809097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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
• Patient Sex: Unknown