MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA FLOW 5F; PERCUTANEOUS CATHETER

Model Number MV-A5125ST

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

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.Investigation found that both the diameter and the material of the fragment match the sofia coil drawing.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces that exceed the strength of the coil.

Event Description

It was reported that a sofia aspiration catheter was used to treat a thrombus in the right m1 segment of the middle cerebral artery.During deployment of a stent retriever through it, slight resistance was felt.After the deployment of the stent retriever, the stent retriever was withdrawn through the sofia.When the tron was observed, the part closer to the distal end was found to be closed.The stent retriever was not used and a direct aspiration first pass technique (adapt) was performed with the sofia.Angiography was performed and confirmed recanalization and the procedure was completed.The stent retriever was returned to the manufacturer, a competitor, for investigation and a metal fragment was found to be attached to the stent retriever during the investigation.As a result of the analysis, the metal fragment was determined not to originate from the stent retriever.There was no reported injury to the patient or intervention performed.The fragment was returned to microvention for analysis.

• Brand Name: SOFIA FLOW 5F
• Type of Device: PERCUTANEOUS CATHETER
• 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: 12791595
• MDR Text Key: 282560750
• Report Number: 2032493-2021-00448
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987892098499
• UDI-Public: (01)04987892098499(11)210104(17)231231(10)210104543
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: MV-A5125ST
• Device Lot Number: 210104543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• 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