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

Model Number	N/A
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation: manager.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.
Event or Problem Description
The user facility reported that they are having issues getting air into the tr band.They believe the issue is with the tip of the syringe not seating properly in the band port.There was no blood loss.There was no patient injury and/or required medical or surgical intervention.The event occurred after the patient's heart catheterization procedure.Additional information was received on 25jan2024: 18 ml's of air were injected into the tr band when it was applied.A glidesheath was the other device used at access site.Holding air was not the issue the issue was getting air into the tr band.It appeared that they could not get a good seal on the syringe tip to the balloon port.Once air was in the tr band it held the air.They used a second tr band when the issue occurred.There was no injury or hematoma due to the issue.No noticeable damage to the device.Patient condition was stable.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.One tr band and inflator were returned to terumo medical corporation for assessment.The sample was subject to visual analysis.No damage or deformities were noted on the inflator or band.There is 14ml left in the balloon assembly.The sample was subject to functional testing.The inflator tip was inserted into the check valve to check the seal.There were no issues with inserting or connecting the inflator to the check valve.The inflator was used to inflate the tr band.There were no issues inflating the tr band with the returned inflator.The complaint cannot be confirmed for inflation difficulties because the failure mode could not be replicated, and the inflator was able to inflate and deflate the band without issue.The exact root cause cannot be determined.It is possible the inflator tip was not fully inserted into the check valve initially, leading to insufficient inflation.Review of the device history record (dhr) showed there were no issues noted during 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 design failure mode and effects analysis (dfmea).

• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 18728687
• Report Number: 1118880-2024-00012
• Device Sequence Number: 12540385
• Product Code: DXC
• UDI-Device Identifier: 00389701011356
• UDI-Public: 00389701011356
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/18/2024

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 Expiration Date: 05/01/2026
• Device Model Number: N/A
• Device Catalogue Number: TRB29-LRG
• Device Lot Number: 0000453083
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 02/18/2024
• Supplement Report FDA Received Date: 04/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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
• Patient Sex: Unknown