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

Model Number N/A

Device Problem Inflation Problem (1310)

Patient Problem Blood Loss (2597)

Event Date 07/01/2019

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 they inflated the tr band airbag it would not hold pressure.They then tried to inflate it once again and a third time, but all attempts failed.A new tr band was opened and used to apply pressure to the patient.The patient was reported to be in stable condition.The procedure outcome was successful.Additional information was received on july 19, 2019.The blood loss was less than 250cc.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One used regular tr band assembly was returned for product evaluation.Visual inspection revealed that communication port which attaches the two balloons was ripped apart.Leak testing was attempted to be performed on the device.However, due to the communication port being open the balloons were not able to be inflated.Microscopic images were taken, no other anomalies were noted with other components.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the balloons were attempted to be separated prior to inflating which could have caused reported event.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8813230
• MDR Text Key: 151782118
• Report Number: 1118880-2019-00177
• 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: 07/22/2019

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: XD27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1