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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 while the patient had a tr band on, they started to bleed profusely.The patient stated that he heard a pop and then the blood started going everywhere.The tr band was still inflated, and the velcro was still attached.It had been 15 minutes since 3ccs of air had been removed, there was still 11ccs in it.The device was removed and replaced with a new tr band.There was approximately 20-30cc of blood loss.They stated it was messy, however there were no huge puddles of blood.The floor nurse went in and was able to hold manual pressure very quickly.The tr band was on for at least 45 minutes prior to removing any air from the band.The patient was in stable condition.The procedure outcome was a success.Additional information was received on (b)(6) 2020.The procedure performed prior to the use of the tr band device was a cardiac catheterization procedure.Additional information was received on 05jan2021.Manual pressure was only held until the second tr band was put on.

Manufacturer Narrative

This reported event has been deemed not reportable based off the investigation of the actual device; inspection of the returned sample upon receipt found that the device had no damage.The device involved in this complaint has been verified to be of normal product; therefore, is not a reportable 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: 11128906
• MDR Text Key: 229630070
• Report Number: 1118880-2020-00351
• Device Sequence Number: 1
• Product Code: DXC
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: TRB29-LRG
• Device Lot Number: YD24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6FR GLIDESHEATH SLENDER.; 6FR GLIDESHEATH SLENDER
• Patient Age: 49 YR
• Patient Weight: 86