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

Model Number N/A

Device Problem Gas/Air Leak (2946)

Patient Problem No Information (3190)

Event Date 04/01/2019

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 a probable tr band valve failure (leakage); the system deflates itself.The airbag deflates itself and causes a lack of compression and thus there's bleeding at the puncture site.The patient's condition and procedure outcome was reported to be unknown.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the completed investigation results.One used regular tr band assembly along with the inflator was returned for product evaluation.Visual inspection revealed that there were no anomalies noted with tr band inflator.Microscopic and fluoroscopic images of the air inlet port were taken.No anomalies were observed.Leak testing was performed, and the returned 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 band was left aside for 20 hours (>12 but <24 hours).After 20 hours, the tr band was deflated, and 5 ml of air was measured which did not meet the required specification of greater than or less than 13ml.The tr band was inflated and then submerged under water.There were bubbles observed along the area where the inflation balloon is bonded to the air inlet port/valve indicating presence of leakage.Based on the returned device, the complaint could be confirmed for device leaks air due to improper valve bonding during manufacturing.Terumo has determined the reported event to be manufacturing related and is being further investigated.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date and to update.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: 8517733
• MDR Text Key: 142089003
• Report Number: 1118880-2019-00082
• 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
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: WN26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1