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

Model Number	TRB29-LRG
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	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted, d6b: explanted date: device was not explanted, e3: occupation: rt.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 tr band was placed on patient in normal fashion.The sheath was pulled, and hemostasis was achieved.The patient was transferred to stretcher, the staff then noticed blood leaking from site.A new tr band was applied.The estimated blood loss was less than 250cc.There was no patient injury.The procedure performed was a heart catheterization.Additional information was received on 23may2025: approximately 15mls of air were injected in each tr band.Then approximately five to six minutes after filling each tr band per protocol blood leakage was noted at the entry site.They confirmed that the tr band balloons lost air and deflated.There was no damage noted to either device.The patient was confirmed to be stable with no issues as a result of the event.
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 and packaging label were returned to terumo medical corporation for assessment.The sample was subject to visual analysis.The inflation tubing is detached from the connection tube and was not returned with the sample.One tr band and packaging label were returned for assessment.The sample was subject to visual analysis and the inflation tubing is detached from the connection tube.The inflation tubing was not returned with the sample.The complaint can be confirmed for an inflation tube detachment.The exact root cause cannot be determined.Review of device history record (dhr) 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 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: 22290862
• Report Number: 1118880-2025-00079
• Device Sequence Number: 8271153
• Product Code: DXC
• UDI-Device Identifier: 00389701011356
• UDI-Public: (01)00389701011356(17)270401(10)0000717118
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 06/18/2025

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: 0000717118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GLIDESHEATH SLENDER; TIGER CATHETER
• Patient Sex: Unknown