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

Model Number	TRB29-LRG-01
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical received a medwatch report (b)(4).The medwatch event description stated that: ¿tr band was placed on patient post heart cath.Patient returned to prep/recovery from cath lab with 15cc of air in patients band.Every 15 minute checks were completed on patient.Air was to be removed from tr band two hours post cath.When nurse attempted to start removing air, only 1cc of air was in the band.14cc of air had leaked out very slowly over a two hour period.No hematoma, or bleeding from site.¿.
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: not provided due to hospital policy.A6: race: not provided due to hospital policy.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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.

• Brand Name: TR BAND
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): Terumo Medical Corporation (TMC); 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: 50841506
• Report Number: 1118880-2026-00658
• Device Sequence Number: 13276830
• Product Code: DXC
• UDI-Device Identifier: 00389701012476
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: TRB29-LRG-01
• Device Catalogue Number: TRB29-LRG-01
• Device Lot Number: 0001472248
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2025
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 145 LB
• Patient Race: White