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 08/08/2018

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(4).The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

Event Description

The user facility reported that the tr band device leaked air.The ccl had placed a tr band post radial procedure and the balloon on the band leaked out air overtime and created a hematoma on the patient.It was reported that this was the first tr band this happened with and the physician placed the band on the patient.The procedure was successful and there was no blood loss from the patient due to the tr band issue.Additional information was received on september 5, 2018.Once the nurse saw the patient had a hematoma, they removed the band and held pressure to evacuate the hematoma.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no device return the exact cause of the reported event cannot be definitively 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 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: 7850192
• MDR Text Key: 119337022
• Report Number: 1118880-2018-00119
• Device Sequence Number: 1
• Product Code: DXC
• 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: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 09/11/2018
• Supplement Dates FDA Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SLENDER SHEATH
• Patient Outcome(s): Required Intervention