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

Model Number N/A

Device Problem Inflation Problem (1310)

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Date 10/21/2019

Event Type  Injury  

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 tr band would not pump and kept leaking.They had to quickly hold pressure and apply a new one.Additional information was received on 23oct2019.Manual pressure was held in large hematoma.A 2nd tr band could not be used.The estimated blood loss was unable to be quantified.The patient was in stable condition.The procedure outcome resulted in a large hematoma.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section and to provide the completed investigation results.One used tr band assembly was returned for product evaluation.The inflator was not received for product evaluation.Visual inspection was performed.Microscopic and fluoroscopic images of the air inlet port were taken.No anomalies were observed.Functional testing was performed.Leak testing was performed on the device.A tr band inflator was obtained and used to inflate the tr band with 15 ml of air.The inflated tr band and stayed inflated for greater than 12 hours.An inflator was inserted into the one-way valve and retracted past the 20ml graduation mark and released.The plunger settled at 15ml.This test confirmed no air leakage.The air inlet valve was dissected from the inlet port and viewed under microscope, no foreign matter that could obstruct airflow was observed.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 investigation results verified the returned sample was of the normal product.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: 9328025
• MDR Text Key: 166561588
• Report Number: 1118880-2019-00319
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

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: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: XH18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 75