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

Model Number TRB24-REG

Device Problem Gas/Air Leak (2946)

Patient Problem Hematoma (1884)

Event Date 07/09/2021

Event Type  malfunction  

Event Description

Air leaked during the procedure.Right radial found a hematoma.Gained control of it and sent the patient to hvc.Procedure was completed by going through the right groin.Manufacturer response for tr band, (brand not provided) (per site reporter): emailed field rep.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 12286970
• MDR Text Key: 265420682
• Report Number: 12286970
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRB24-REG
• Device Catalogue Number: TRB24-REG
• Device Lot Number: 0000039683
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29200 DA