MAUDE Adverse Event Report: SONAVEX, INC. ECHOMARK LP IMPLANTABLE RADIOGRAPHIC MARKER

Model Number 2000

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

Patient Problem Insufficient Information (4580)

Event Date 01/23/2020

Event Type  Death  

Manufacturer Narrative

Communication initially received through study stated the event was unrelated to the device and unrelated to study. New information received from the investigator on 1/28/2021 indicated possible device involvement based on occurrence in 30 day post-operative window and lack of explicit exclusionary evidence. No autopsy was performed. Cause of death is unknown. No evidence of device involvement or malfunction provided.

Event Description

Patient death reported to have occurred in 30 day postoperative window. Cause of death unknown. No indication of implant involvement.

• Brand Name: ECHOMARK LP
• Type of Device: IMPLANTABLE RADIOGRAPHIC MARKER
• Manufacturer (Section D): SONAVEX, INC.; 2835 o'donnell st; suite 200; baltimore MD 21224
• Manufacturer Contact: michelle zwernemann ; 2835 o'donnell st; suite 200; baltimore, MD 21224 ; 4438623223
• MDR Report Key: 11646254
• Report Number: 3014680735-2021-00002
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: B53620001
• UDI-Public: B53620001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/26/2020
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: P-14526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 74 YR
• Patient Weight: 92
• Patient Outcome(s): Death