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

Model Number N/A

Device Problem Inflation Problem (1310)

Patient Problem Blood Loss (2597)

Event Date 10/30/2019

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.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.[medwatch (b)(4).Pdf].

Event Description

Terumo medical received a user facility medwatch report # (b)(4).The event description states: patient received post-cardiac cath in holding unit with tr band in place, with no bleeding initially.On moving patient from stretcher to chair, insertion site beneath the tr band began to pulsatile bleed.Rn attempted to add 1-2 cc of air into air bladder and the bladder would not inflate.Rn immediately placed manual pressure on the catheter site and interventional md was called to holding unit to replaced tr band.Estimated blood loss 20 cc.

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 return of the actual device, 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: 9575011
• MDR Text Key: 174513230
• Report Number: 1118880-2019-00371
• 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: User Facility
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR