MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION TR BAND; CLAMP, VASCULAR

Model Number	TRB29-LRG
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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
The user facility reported that the percutaneous coronary intervention (pci) was performed via the right radial artery.Upon completion of the procedure, a tr band was applied, inflated, and the sheath was removed.After adjusting the air in the band and removing the syringe, the physician noted that the balloons appeared to be losing air and bleeding was occurring.The band was replaced with a new band, and there were no further issues with recovery.Blood loss was less than 250 cc.No patient injury or medical/surgical intervention was required.Additional information was received on 21 apr 2025: the volume of air injected cannot be verified because the lab does not record the air inserted into the band.Deflation was identified by the physician immediately after removing the sheath and disconnecting the syringe.There was no noticeable damage to the device.The patient remained stable, with no injury and no hematoma.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3 and provide the completed investigation results.One tr band, inflator, and packaging were returned for assessment.The sample was subject to visual analysis.There are no damage or deformities on the band or inflator.There is 18ml of air left in the band.The sample was subject to leak testing.Approximately 18ml of air was injected into the band and submerged in a water bath for 30 seconds.No leaks were observed from the balloon assembly or check valve.The sample passed leak testing.The sample was subject to additional leak testing per 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 14.5ml 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, a piece of foreign matter was found in the check valve.The complaint cannot be confirmed for air leakage issues because the band passed all leak testing.However, it can be confirmed for foreign matter.The exact cause of the foreign matter cannot be determined.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.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: 21998064
• Report Number: 1118880-2025-00057
• Device Sequence Number: 18303125
• Product Code: DXC
• UDI-Device Identifier: 00389701011356
• UDI-Public: (01)00389701011356(17)270101(10)0000641557
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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
• Device Catalogue Number: TRB29-LRG
• Device Lot Number: 0000641557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White