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

Model Number	TRB24-REG
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: unit manager.The actual device was not 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 type of incident/problem was a malfunction during or after use.The level of effect was no apparent harm, but it reached the patient/person and was inconvenient.The incident details are as follows: the patient was received from the catheterization laboratory with an old tr band in situ on the right arm over the ulnar access site (green tab on the balloon).While settling the patient in the room and attaching monitors, the right hand was noted to be dusky purple and swollen.Immediate pressure was applied by a co-worker.The charge nurse was made aware and the interventionalist was paged.The interventionalist stated that the band was mispositioned and needed a second band.The medical doctor re-positioned the band.A second band was obtained from the catheterization laboratory by the writer.The interventionalist was gone, and manual pressure was still being applied.Nurses from the catheterization laboratory came into re-apply the second tr band.Additional information and impact of the incident include that manual pressure was applied to the arm and a second tr band was applied.Manual pressure was held for a total of 1.5 hours.The patient was affected by this incident.Unexpected or prolonged care was required.This was the first time this problem occurred.There were no other devices or incident factors.The procedure involved was arterial compression post-cardiac angiogram, and the device was not implanted.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned, so an evaluation could not be conducted.The complaint cannot be confirmed for a positioning issue because a sample was not returned for assessment.Without a sample, the exact root cause 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 and the device was released in a conforming state.Currently, no action is recommended since the risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to correct section g3.Upon internal review it was found that the g3 date on the initial mdr was incorrect; therefore, a correction is being made.

• 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: 21741808
• Report Number: 1118880-2025-00044
• Device Sequence Number: 12945499
• Product Code: DXC
• UDI-Device Identifier: 00389701011356
• UDI-Public: (01)00389701011356(17)261101(10)0000584226
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2025

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: TRB24-REG
• Device Catalogue Number: TRB24-REG
• Device Lot Number: 0000584226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 04/18/2025; 04/14/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/30/2025; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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 Sex: Unknown