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

Model Number N/A

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

E3: occupation: manager.H4: device manufacture date: unknown, as the involved product lot # was unknown.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.The production lot # was not provided by the user facility, which prevented a meaningful review of the device history record.

Event 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.

Manufacturer Narrative

This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.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 device history record (dhr) cannot be completed due to the unknown lot number.Currently no action is recommended since this risk evaluation is within the predetermined limits in the design failure mode & effects analysis (dfmea).

• Brand Name: TR BAND RADIAL COMPRESSION DEVICE
• Type of Device: 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: 18728702
• MDR Text Key: 336623896
• Report Number: 1118880-2024-00013
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GLIDESHEATH