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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 04/11/2023

Event Type  Injury  

Manufacturer Narrative

D4: catalog number: requested, unknown d4: lot number: requested, unknown d4: expiration date: unknown due to unknown catalog and lot number combination d4: udi: unknown due to unknown catalog and lot number combination d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted h4: device manufacture date: unknown due to unknown catalog and lot number combination.The product code/lot # combination was not provided by the user facility, which prevented a meaningful review of the device history.The actual device is not available for return.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.

Event Description

Terumo medical received an fda medwatch report # mw mw5147997 the event description states that the patient developed hematoma at tr (transparent radial artery) band site and required intervention.

Manufacturer Narrative

This report is being sent 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.The complaint cannot be confirmed for closure procedural complications because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.Review of device history record (dhr) cannot be completed due to the unknown lot number.Currently no action is recommended since this risk evaluation is within the predetermined limits in the design failure mode and effects analysis (dfmea).

Event Description

Additional information was received on 01 feb 2024: the patient had a left heart catheterization & left and right coronary system angiography with ultrasound-guided right radial artery access.Patient was stable and discharged to home.

• Brand Name: TR BAND RADIAL COMPRESSION DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 4103927218
• MDR Report Key: 18461064
• MDR Text Key: 332250201
• Report Number: 1118880-2023-00461
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Other
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 164 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American