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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy a2: age & date of birth: requested, not provided due to hospital policy a3a: sex: requested, not provided due to hospital policy a4: weight: requested, not provided due to hospital policy a5: ethnicity: requested, not provided due to hospital policy a6: race: requested, not provided due to hospital policy d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e3: occupation: inventory and special projects coordinator 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 reported information: following a cardiac cath, the tr band was placed and 15ml's of air was injected into the band.Then 5 was then replaced.Two minutes, the tr band started to deflate/lost pressure in the balloon area.There was no noticeable damage to the device.The blood loss was less than 250cc, and the patient was stable.The patient did bleed and developed a hematoma; however, was stable and okay afterwards.The size of the hematoma was unknown.A second tr band was placed on to provide pressure to the hematoma.
Additional Manufacturer Narrative
One tr band and packaging label were returned for assessment.The sample was subjected to visual analysis.No damage or deformities were noted on the band or balloon assembly.There is 1ml 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, a piece of 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 air leakage issues.The cause is foreign matter in the check valve.Manufacturing was notified about this issue.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: 24816277
• Report Number: 1118880-2026-00088
• Device Sequence Number: 9686512
• Product Code: DXC
• UDI-Device Identifier: 00389701011349
• UDI-Public: (01)00389701011349(17)280401(10)0001414638
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 0001414638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2025
• 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