MAUDE Adverse Event Report: MICROVENTION, INC. ERIC 6; CLOT RETRIEVER

Model Number ER176044

Device Problem Fracture (1260)

Patient Problem Loss of consciousness (2418)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was discarded at the user facility and not returned to the manufacturer for investigation.Medical imaging and reports are being sought but have not yet been provided.The alleged product issue and event as described could not be confirmed.If imaging, reports, further information is received at a later date, an investigation will be performed and a supplemental report will be submitted.

Event Description

It was reported that a clot retriever used to remove clot in the ica detached from the pusher.Several unsuccessful attempts were made to remove it and it remained in the ica.The patient¿s condition was the same as upon arrival; they were unconscious.The ica was occluded when they arrived and remained occluded after the procedure.

• Brand Name: ERIC 6
• Type of Device: CLOT RETRIEVER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18509245
• MDR Text Key: 332869836
• Report Number: 2032493-2024-00049
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00810170018824
• UDI-Public: (01)00810170018824(11)230615(17)280531(10)0000377650
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K211120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/24/2023

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: ER176044
• Device Lot Number: 0000377650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/24/2023
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• 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): Other; Required Intervention
• Patient Sex: Male