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

Model Number N/A

Device Problem Deflation Problem (1149)

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

Event Date 11/30/2021

Event Type  malfunction  

Event Description

The user facility reported that the tr band was not holding air as well as they are used to.The patient was stable, and the procedure outcome was good.Additional information was received on 02december2021: the procedure performed was a left heart catheterization.Hemostasis was achieved with the tr band.There did not appear to be any damage to the tr band.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.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.A review of the device history record of the product code/lot# combination was conducted with no findings.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One tr band was returned for product evaluation.The returned sample included the final band assembly.The sample was subjected to visual analysis.Approximately 1ml of air was pulled from the balloon.No signs of damage or deformation was found on the tr band.The tr band was subjected to leak testing.Approximately 18ml of air was injected into the balloon.The sample was submerged in a water bath for approximately 30 seconds to check for the presence of air bubbles.No air bubbles were observed.The sample passed leak testing.The check valve was deconstructed to check for damage or the presence of foreign matter.Two strands of foreign matter were found.The complaint can be confirmed for foreign matter contamination.The operation quality engineer (qe) was contacted, and a non-conformance was initiated to address this issue.The non-conformance report will contain root cause analysis and corrective actions.The dhr review determined that the device was in a conforming state when released from terumo control.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: TR BAND
• 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: mary o'neill ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13095600
• MDR Text Key: 286667847
• Report Number: 1118880-2021-00218
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00389701011349
• UDI-Public: 00389701011349
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: 0000054515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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