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 06/07/2019

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 the at the end of cardiac angiogram, the ic cleaned the radial access site and prepped the tr band for placement.It was noted that large balloon was stuck to opposing strap.The ic was advised to gently pull the large balloon away from strap; however, he grabbed the small balloon.He was then redirected to the large balloon and he was able to pull it away from strap.The tr band was fastened to patients arm and air was injected.However, the balloons did not inflate.The new band was opened and placed.Inflation was completed without issue.Upon inspection of first band it was noted that connection between two balloons was partially separated.The patient was stable and discharged.Blood loss was less 250cc.The procedure was successful.There were no other devices or equipment used with the reported product.

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.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 small balloon indicating leakage of air.Visual inspection revealed that the communication port which attaches the small balloon and the large balloon was ripped.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 separation of the balloons caused the rip in the communication port which contributed to the 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: 8743599
• MDR Text Key: 149514056
• Report Number: 1118880-2019-00152
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00389701011356
• UDI-Public: 00389701011356
• 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
• Report Date: 06/28/2019

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: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: TRB29-LRG
• Device Lot Number: XC28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1