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 01/22/2020

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 they had an issue with the involved tr band.The scrub tech said it would not stay inflated.Estimated blood loss was less than 250cc's.There was no patient injury/medical or surgical intervention.The patient was stable.The procedure was completed successfully.There were no other devices or equipment used with the reported product.Additional information was received on 03february2020: the procedure performed was unknown but is believed it had been a diagnostic left heart cath.Another tr band was used to achieve hemostasis.No hematoma was present.

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 tr band assembly and its inflator were returned for product evaluation.Visual inspection revealed that there was no damage or gross anomalies were observed.Leak testing was performed on the device.The tr band inflator was used to inflate the tr band with 15 ml of air.The inflated tr band stayed inflated for 24 hours.The inflator was connected to the inflation balloon and retracted past the 20 ml graduation mark and released.The plunger settled at the 15 ml graduation mark.The tr band passed leak testing because more than 13ml of air remained in the tr band.The tr band was inflated with 18 ml of air and submerged in water.No air bubbles were observed along with the seals of the large and small balloons and no air bubbles were seen at the inflation balloon.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 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
• MDR Report Key: 9732452
• MDR Text Key: 199893014
• Report Number: 1118880-2020-00032
• 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: 02/20/2020

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: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: XM28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 02/28/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 60