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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Expiration date - unknown due to unknown lot number.Udi - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Establishment name: unknown.Establishment address - unknown.Occupation - unknown.Device manufacture date - unknown due to unknown lot number.The actual device was not returned, therefore an evaluation of the actual device was unable to be conducted.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.With no device return, the exact cause of the reported event cannot be definitively determined based on the available information.[mw5080638].

Event Description

This report is being submitted in response to user facility medwatch report # mw5080638.The event description states the following: a patient was a stemi transferred to the facility and was sent immediately to the cath lab.Upon arrival to the unit the cath lab was informed that his right radial artery was leaking from the tr band and originally had 14ml of air currently and no leaking occurred.About two hours later from the patient's recovering his tr band was leaking so they instilled 2 more ml's of air which did not resolve the issue.Therefore 2 more ml's were added which did stop the bleeding.At this point the patient's tr band should have had 18ml of air.Then 2ml's of air was going to be removed from the tr band which should have had 10ml of air left inside.When more air was to be released the tr band was completely empty and it is possible it had a small leak.After all of the air was removed completely out the tr band and covered the area with a 2x2 and tegaderm.Hemostasis was maintained and no further complications occurred.

• Brand Name: UNKNOWN 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: 8077963
• MDR Text Key: 128952691
• Report Number: 1118880-2018-00166
• 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,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2018
• 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