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

Model Number N/A

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.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.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 the tr band would not stay inflated.Another tr band was used for radial closure to complete the case.The patient was stable.The procedure outcome was successful.Additional information was received 31 dec 2019.The procedure performed was a left heart catheterization.The tr band did not hold any air.Hemostasis was achieved by holding pressure and a new tr band was used.There were no other devices or equipment used with the reported product.There was no blood loss.

Manufacturer Narrative

This report is being submitted as follow up no.1 to correct section d10 as it was initally reported that the actual sample was available, however has been confirmed to not be available, to update section h3 and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

Manufacturer Narrative

This report is being submitted as follow up no.3 to update section h3, and to provide the completed investigation results.One used regular tr band assembly and its inflator was returned for product evaluation.Visual inspection was performed.Fluoroscopic images of the air inlet port were taken.No anomalies were observed.Functional testing was performed.The sample was subjected to leak testing.The inflator was used to inflate the tr band with 15 ml of air.The inflated tr band was then submerged underwater.No bubbles were observed along the seals of the large and small balloons; however, air bubbles were seen at the air inlet valve.The valve was then deconstructed and examined under the microscope.Foreign matter was found in the air inlet port/valve.The sample was sent out for ftir testing to further analyze the nature of the foreign matter.The foreign matter was found to be consistent with polyacrylonitrile butadiene styrene.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that the foreign matter observed did not allow the air inlet valve to properly close which may have caused the reported event.However, the exact cause of the reported event cannot be definitively determined based on the available information.

Manufacturer Narrative

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.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 9613191
• MDR Text Key: 199314351
• Report Number: 1118880-2019-00376
• 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,Followup,Followup
• Report Date: 01/21/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: XL09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 01/24/2020; 03/05/2020; 04/09/2020
• Supplement Dates FDA Received: 02/04/2020; 03/30/2020; 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1