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 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Healthcare professional - unknown.Initial reporter: occupation - stock manager.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 at the end of the procedure and when trying to gain hemostasis on the radial artery wound, the tr band was attempted to be inflated but the balloons would not inflate therefore hemostasis was not achieved.Manual compression was applied and a new tr band was quickly issued to resolve the matter.There was no harm to the patient.

Manufacturer Narrative

This report is being submitted as follow up no.2 to update device evaluated by mfr, and to provide the completed investigation results.One tr band along with its inflator were returned for product evaluation.Visual inspection revealed there was no damage seen at the small and large balloons.There were no tears or hole in the balloons or at the air inlet port balloon.All welds on the device were consistent, there were no tears or holes in the welds.Functional testing was performed.While attempting to perform air leakage testing which requires inflating the device using the inflator, the device immediately deflated after the plunger was disconnected from the air inlet port.An x-ray image was taken of the air inlet port and no damage or gross anomalies were observed in the image.The air inlet valve was dissected from the device and observed under microscope.Foreign matter was discovered on the valve.The valve was sent out for ftir testing to analyze the nature of the foreign matter.The ftir result indicated that the foreign matter is a form of cellulose.A scratch mark was also observed on the valve and viewed under microscope.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 for the air inlet valve to properly close therefore causing air to leak out.However, the exact cause of the reported event cannot be definitively determined based on the available information.

Event Description

Additional information was received on 18nov2019.The procedure was an angio procedure and percutaneous coronary intervention (pci).The blood loss was less than 250cc.

Manufacturer Narrative

This report is being submitted as follow up no.1.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

Manufacturer Narrative

This report is being submitted as follow up no.1 to correct sections b1 and h1 to malfunction as they were inadvertently reported as serious.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 9310671
• MDR Text Key: 166019311
• Report Number: 1118880-2019-00326
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: XD18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 11/18/2019; 12/20/2019; 08/25/2020
• Supplement Dates FDA Received: 12/18/2019; 12/20/2019; 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention