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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: cardiac cath lab / ep lab manager interventional r.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: following a left heart catheterization while the patient was in the room, the bladder of the tr band did not hold/lost air.The bladder was noted to be flatter upon removal.A terumo 5/6 french slender sheath was used in the access site during the procedure.The tr band started to lose air approximately 5 minutes after initial inflation.15 mls of air was initially injected into the tr band.Manual pressure was held until a second band was applied; however, there was active bleeding when applying the new band.Hemostasis was achieved.The estimated blood loss was about 5cc.The patient was in stable condition and released as planned.No swelling, pain, numbness, faint pulse, or weakness was noted.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for air leakage issues because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.Review of the device history record 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: 24642864
• Report Number: 1118880-2026-00031
• Device Sequence Number: 9786667
• Product Code: DXC
• UDI-Device Identifier: 00389701011349
• UDI-Public: (01)00389701011349(17)280601(10)0001472622
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/19/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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
• Patient Sex: Unknown