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 Problems Hematoma (1884); Blood Loss (2597)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

Expiration date - unknown due to the lot number being unknown.Udi - unknown due to the lot number being unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to the lot number being unknown.The actual device has been 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 the patient developed a hematoma proximal to the tr band, post catheterization in the cardiovascular unit.This hematoma was expressed out to satisfaction.The hematoma was 2.5 cm in diameter.Hemostasis was achieved.The patient was reported to be in stable condition.Blood loss was less than 250 cc.Procedure outcome was stasis achieved.Additional information was received on april 19, 2019.The procedure being performed was a trans radial intervention.

Manufacturer Narrative

The actual device was confirmed to be not available and was not received, the device return date was inadvertently submitted in the initial mdr.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: 8578952
• MDR Text Key: 144001655
• Report Number: 1118880-2019-00095
• 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
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• 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 Returned to Manufacturer: 04/26/2019
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 76