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	07/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical corporation received the following information: it was reported that the patient had a tr band placed with 12ml of air post radial left heart catheterization.When they initially started to remove air per protocol no issues were noted, however they only removed 7mls of air and the tr band was empty.Hemostasis was achieved by the tr band.There was no blood loss and the patient remained in stable condition.The location of the leak is unclear.
Event or Problem Description
Terumo medical corporation received the following information: it was reported that the patient had a tr band placed with 12ml of air post radial left heart catheterization.When they initially started to remove air per protocol no issues were noted, however they only removed 7mls of air and the tr band was empty.Hemostasis was achieved by the tr band.There was no blood loss and the patient remained in stable condition.The location of the leak is unclear.
Additional Manufacturer Narrative
E3: occupation: nurse director.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 label were returned to terumo medical corporation for assessment.The sample was subjected to visual analysis.No damage or deformities were observed on the band or inflator.There is 0ml 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 inflation port or balloon assembly.The sample passed leak testing.The check valve was deconstructed to check for damage or foreign matter.Upon deconstruction, foreign matter was found.One tr band, inflator, and packaging label were returned and the sample passed leak testing.The check valve was deconstructed and foreign matter was found.The complaint can be confirmed for foreign matter in the check valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with terumo medical corporation specifications and procedures.A corrective action was initiated for this issue.

• 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: 50483570
• Report Number: 1118880-2026-00614
• Device Sequence Number: 10396204
• Product Code: DXC
• UDI-Device Identifier: 00389701012469
• UDI-Public: (01)00389701012469(17)280901(10)0001603093
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: 0001603093
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• 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: 08/02/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2026
• 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