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 Code Available (3191)

Event Date 02/12/2020

Event Type  Injury  

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.Device manufacture date - unknown due to unknown lot number.(b)(4).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 return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

Event Description

The user facility reported that the involved tr band was used.There was a radial complication that had occurred.The complication was observed 1.5 hours after the tr band placement and was so severe that it required a fasciotomy.It sounded like either the band was placed too distal to artery entry site and the doctor took a very aggressive angle for access resulting in a proximal vessel entry site.Additional information was received on 21feb2020.The procedure that was performed prior to the tr band being used was a heart catheterization.A 6fr sheath was used.The radial artery was accessed.The tr band was removed, and an hour and a half later, the patient develop symptoms of compartment syndrome.The patient's condition was stable.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• Manufacturer Contact: theresa mussaw ; 950 elkton blvd.; elkton, md ; 2837866718
• MDR Report Key: 9804763
• MDR Text Key: 182520490
• Report Number: 1118880-2020-00006
• 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,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• 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: 02/12/2020
• 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
• Patient Outcome(s): Other; Required Intervention