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

Model Number N/A

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

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 when the tr band device inflates on the radial artery, there was a leak on the bracelet.Another tr band was used to void a hematoma on the wrist.There was no harm to the patient.

Event Description

Additional information was received on 19september2019: the procedure performed was a coronary artery.There was a slow leak in the tr band.The new tr band achieved hemostasis.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information.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.1 to update the h3 section and to provide the completed investigation results.One used large tr band assembly was returned for product evaluation.The inflator was not received for product evaluation.The device was decontaminated per terumo medical corporation's policies and procedures.The returned device was subjected to visual inspection.Microscopic and fluoroscopic images of the air inlet port were taken.No anomalies were observed.Leak testing was performed.A tr band inflator was obtained and used to inflate the tr band with 15 ml of air.The inflated tr band was then submerged underwater.No bubbles were observed along with the seals of the large and small balloons but air bubbles were seen at the air inlet valve.The valve was then deconstructed and examined under the microscope.Foreign matter was found in the air inlet port/valve.Based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.However, the exact cause of the reported event cannot be definitely determined based on the available information.Terumo is further investigating the reported event.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8952243
• MDR Text Key: 159354806
• Report Number: 1118880-2019-00251
• 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,Followup
• Report Date: 08/30/2019

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: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: XA07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 09/19/2019; 11/04/2019
• Supplement Dates FDA Received: 10/11/2019; 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1