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)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation: cardiac cath lab / ep lab manager interventional r.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 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 5-10 minutes after initial inflation.It was unknown how many ml's were initially injected.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 5-10cc.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 update section h3, and to provide the complete investigation results.This reported event has been reassessed and deemed not reportable based upon the investigation of the actual sample.One tr band and packaging label were returned for product assessment.The sample was subjected to visual analysis.No damage or deformities were noted on the band or balloon assembly.There is 9ml 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.No air bubbles were observed from the balloon assembly or inflation port.The sample passed leak testing.The sample was subject to additional leak testing.15ml of air was injected into the band and the band was placed in its holder for 12-24 hours.After 12 hours, the air was removed and 14ml of air remained in the band.The sample passed additional leak testing.The check valve was deconstructed to check for damage or foreign matter.Upon deconstruction, no damage or foreign matter was found.One tr band and packaging label were returned for assessment, and the sample passed all leak testing.The check valve was deconstructed, and no damage or foreign matter was found in the valve.The complaint cannot be confirmed for air leakage issues because the returned sample passed all leak testing and no damage or foreign matter was found in the check valve.No failure was detected on the returned device.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 device was within manufacturing and design specifications when it was released from terumo medical corporation control.Therefore, this event is currently deemed a non-reportable event.

• 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: 24642866
• Report Number: 1118880-2026-00030
• Device Sequence Number: 15899222
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• 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: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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