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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 05/09/2019

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 that the tr band was placed and the patient was sent to the recovery unit.One hour post application, bleeding was noted from the puncture site, before any air had been removed manually from the band.The band was removed, manual pressure was applied for 5 minutes, a new tr band was applied, the restarted normal protocol.The patient was discharged with no issues, there was a two hour extended stay.The patient was of normal body habitus.The blood loss was less than 250cc's.The procedure was completed successfully and the patient is in stable condition.Additional information was received june 24, 2019: the band lost air on its own before the one hour time had elapsed when air was normally removed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in the d10 section, and to update the h3 section.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.2 to update the h3 section and to provide the completed investigation results.One used regular tr band assembly was returned for product evaluation.The inflator was not returned for product evaluation.Visual inspection revealed no anomalies with the balloons or the air inlet port.Leak testing was conducted, a tr band inflator was obtained and 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.No bubbles were observed along with the seals of the large and small balloons nor along with the air inlet port.The inflated band was left aside for 20 hours (>12 but <24 hours).After 20 hours, the tr band was deflated, and 13 ml of air was measured which conforms to the required specification of less than13ml.No leak was present during testing.Based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.The investigation results verified that the returned device was the normal product.However, the exact cause of the reported event cannot be definitely determined based on the available information.

Event Description

Additional information was received on 13august2019.Per cmdsnet report number: s-2137.The event description states: " that tr bands spontaneously deflated.".

Manufacturer Narrative

This report is being submitted as follow up no.3 to provide additional information to the g3 and b5 section.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8771308
• MDR Text Key: 150402140
• Report Number: 1118880-2019-00163
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: WP17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR