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

Model Number N/A

Device Problem Unintended Deflation (4061)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Address - (b)(6).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.(b)(4).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 over the radial artery after a coronary catheterization.The balloon was blown up but would not hold air.After a couple attempts, they used another tr band to create a patent hemostasis.There was no blood loss and no harm to the patient.The procedure was a success and the patient was in stable condition.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One used regular tr band assembly was returned for product evaluation.Visual inspection revealed that no anomalies were noted.Functional testing was performed.The sample 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 and air bubbles were seen at the inflation balloon.No bubbles were observed along with the seals of the large and small balloons.The inflation balloon was viewed under microscope and a tear was noted at its bonding to the check valve.Based on the returned device, the complaint can be confirmed for airflow issues since air bubbles were observed during leak testing at the check valve.A tear in the inflation balloon was noted on the device which likely caused the air flow issue.The operations quality engineer was notified of this complaint and a non-conformance report (nc) was initiated to further investigate this issue.The device history record was reviewed, and no anomalies were noted.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11363075
• MDR Text Key: 234628275
• Report Number: 1118880-2021-00011
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: 0000004589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLIDESHEATH SLENDER