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

Model Number N/A

Device Problem Gas/Air Leak (2946)

Patient Problems Hematoma (1884); No Code Available (3191)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

Device was not implanted.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 tr band device leaked air.Post cardiac cath, the patient had a size regular tr band placed and after the patient's band was in place, air decreased on it's own creating a hematoma on the patients wrist post procedure and while the patient was in recovery.A staff member reported this happened once with the physician placing the band and once with a tech placing the band.A 15cc was injected initially and then they followed the protocol of removing air until a flash of blood and adding 2cc into the band and everything was fine with the band when the patient left.It was reported that over time the balloon lost air prior to them releasing any.The patient experienced a hematoma.The patient condition is stable.The staff had to hold pressure to evacuate the hematoma.Additional information was received on 9/4/18.The radial procedure itself was successful, the hematoma occurred post procedure.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update and provide the completed investigation results.One tr band regular assembly was returned for evaluation.The tr band regular assembly was returned with the tr band inflator.Visual inspection revealed no gross anomalies.The returned inflator was then used to inflate the tr band regular assembly.After the balloon assembly was inflated, the assembly lost air rapidly.The assembly was then inflated and submerged underwater.A rapid trail of bubbles formed from the air inlet valve.Once the inlet valve was sealed no other leaks were detected in the assembly.Microscopic and fluoroscopic images of the air inlet port revealed no anomalies.The valve was then deconstructed and a fiber was found on the plastic plug in the air inlet port.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 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: mark vornheder ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7863730
• MDR Text Key: 119788624
• Report Number: 1118880-2018-00114
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00038970101349
• UDI-Public: 0038970101349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: WC22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GLIDESHEATH SLENDER
• Patient Outcome(s): Required Intervention