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 03/03/2020

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 balloon on the tr band would not inflate.The technician had to pull another band to place on the patient.There was no issue with the patient, just the tr band balloon.The estimated blood loss was less than 250cc.The patient condition was good, and the procedure outcome was good.There was no patient injury/medical or surgical intervention required.Additional information was received on 04mar2020: the procedure that was performed was a radial heart catheterization.

Manufacturer Narrative

One used large 29cm tr band assembly was returned for product evaluation.Visual inspection revealed that no damage was noted.Fluoroscopic images of the air inlet port were taken.No anomalies were observed.Functional testing was performed.The returned device was subjected to leak testing.The inflator was 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; however, 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, terumo has determined the reported event to be manufacturing related and is being further investigated.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 9889537
• MDR Text Key: 195154923
• Report Number: 1118880-2020-00083
• 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: 03/27/2020

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: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: TRB29-LRG
• Device Lot Number: XL30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 04/29/2020
• Supplement Dates FDA Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1