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

Model Number	TRB24-REG
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for air leakage issues because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.Review of dhr (device history record) 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 this risk evaluation is within the predetermined limits in the hbrt (hazard based risk table).
Event or Problem Description
The user facility reported that the tr band involved balloon deflated shortly after 15cc of air was introduced.A new band was placed safely, and the patient is fine.The procedure conducted was a heart catheterization.The reported event did not result in patient injury or necessitate medical or surgical intervention.There is no direct claim that the reported device caused or contributed to a patient injury or the need for medical intervention.The patient's pre-procedural condition included chest pains.Additional information was received on 16 aug 2024: a6 french & a 6f slender device were used in the access site.It was a tang from trauma.There was no other explanation to why the device could not hold the air.

• Brand Name: TR BAND RADIAL COMPRESSION DEVICE
• 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: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 4103927218
• MDR Report Key: 20214198
• Report Number: 1118880-2024-00134
• Device Sequence Number: 7494736
• Product Code: DXC
• UDI-Device Identifier: 00389701011356
• UDI-Public: (01)00389701011356(17)261101(10)0000590258
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/13/2024

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: 0000590258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• 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: A6 FRENCH & A 6F SLENDER DEVICE
• Patient Sex: Unknown