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 Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

Date of event: requested, not provided.Lot number - requested but not provided.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.Device manufacture date - unknown due to unknown lot number.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 a tr band was placed on the patient after they had a lhc (left heart catheterization) procedure.The patient had radial access via left wrist and was seen by a doctor for a follow-up.The doctor noted deep necrosis of the access site where the tr band was placed and removed.The patient was treated and was stable.The patient was released and sent home with no further complications.The procedure outcome was "a" successful.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information.A follow up report will be submitted once the investigation is complete.

Event Description

Additional information received on december 3, 2018: i was reported that the site was prepped twice in sterile fashion with chloraprep before the procedure as well as before the tr band placement.Tr band functioned as indicated.The patient has had only one follow-up visit with the doctor and the patient is doing fine at this point.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.The evaluation of the actual device could not be conducted due to the device not being returned.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
• MDR Report Key: 8074193
• MDR Text Key: 127262473
• Report Number: 1118880-2018-00160
• 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,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• 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
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6 FR GLIDESHEATH; 6 FR OPTITORQUE TIG; 6 FR GLIDESHEATH; 6 FR OPTITORQUE TIG
• Patient Outcome(s): Required Intervention