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

Model Number	TRB24-REG-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	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical corporation received the following information: it was reported that the tr band was noted to be losing air approximately forty-five minutes after completion of the procedure while the patient was in the post-operative area.When the tr band was removed off the patient, they inflated the balloons and when pressure was put on the balloons, they would deflate.There was no patient injury.Manual pressure was applied and hemostasis achieved.There was no blood loss.The patient remained stable.A total of 18 ml of air was injected into the tr band when it was initially applied to the patient¿s wrist.The tr band is typically left in place for sixty minutes before air titration begins for patients who receive less than fifty units of heparin, and for one hundred and twenty minutes for patients who receive more than fifty units of heparin.In this case, all of the air had already been lost from the tr band when titration was initiated in the post-operative area.There was no noticeable damage to the device, and the device had not been manipulated in any way prior to use or during storage.Before use, the tr band was stored in its original tr band box on enclosed shelves.The type of procedure performed prior to the use of the tr band was left heart catheterization (lhc).
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: (b)(6).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.

• 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 ; +1(949)989-0491
• MDR Report Key: 50935370
• Report Number: 1118880-2026-00665
• Device Sequence Number: 10749768
• Product Code: DXC
• UDI-Device Identifier: 00389701012469
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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-01
• Device Catalogue Number: TRB24-REG-01
• Device Lot Number: 0001328631
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2026
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2025
• 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 Sex: Unknown