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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

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.

Event Description

The user facility reported that when placing the tr band, the air was slowly leaking out.The patient was in stable condition, and the procedure was successful.Additional information was received on june 17, 2019.The procedure performed was a diagnostic catheterization.They placed another tr band to resolve the issue.There was no patient impact.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One large tr band assembly was returned for product evaluation.The inflator was not returned.Visual inspection revealed no anomalies.Microscopic and fluoroscopic images of the air inlet port were taken.No anomalies were observed.Leak testing was performed; a new tr band inflator was used to inflate the tr band with 15 ml of air.Digital pressure was applied to the large and small balloon to verify full inflation.The inflated tr band was then submerged underwater.There were bubbles observed along the air inlet port indicating leakage of air.The valve was then deconstructed and examined under the microscope.Foreign matter was found on the air inlet port/valve.The sample was sent out for ftir testing to further analyze the nature of the foreign matter, the ftir result indicated that the foreign matter was found to be consistent with an alkyd containing short oil, triglyceride, and polyanhydride.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.Terumo is further investigating the reported event.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8743598
• MDR Text Key: 149516660
• Report Number: 1118880-2019-00151
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00389701011349
• UDI-Public: 00389701011349
• Combination Product (y/n): N
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: XE08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1