MAUDE Adverse Event Report: MICROVENTION, INC SOFIA 6F-125CM STR; PERCUTANEOUS CATHETER

Model Number MV-A6125ST

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

Patient Problems Hemorrhage, Subarachnoid (1893); Perforation of Vessels (2135)

Event Date 09/27/2019

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 not returned for evaluation; therefore, an analysis could not be conducted.The root cause cannot be determined.The instructions for use (ifu) identifies rupture as a potential complication associated with the use of this device.

Event Description

It was reported that treatment was attempted for a thrombotic vessel occlusion.A microcatheter and guidewire (not microvention devices) were delivered to the m2 segment of the middle cerebral artery.High resistance had been encountered by the microcatheter in the m1 segment due to "extreme tortuosity of the vessel." the sofia was then delivered to the m2 segment.The microcatheter and guidewire were removed.At that time, the x-ray fluoroscopy was turned off.When the x-ray fluoroscopy was turned back on to perform thrombus aspiration, it appeared that the sofia "went straight" and the middle cerebral artery was perforated.The sofia was withdrawn and successfully removed from the patient.The perforated vessel was embolized and the procedure was successfully completed.There was no reported clinical sequelae as a result of the perforation.

Manufacturer Narrative

Additional information about the event was received from the sales representative, who stated that fluoroscopy had been turned off for approximately 20 seconds.There was extravasation and a subarachnoid hemorrhage; however, the patient did not have any neurological deficits due to the perforation and no medication was administered as intervention.It was also reported that the physician assumed that the tension of deflection that was applied to the sofia was removed when the microcatheter was withdrawn, which could have resulted in the movement of the sofia.

• Brand Name: SOFIA 6F-125CM STR
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 9294045
• MDR Text Key: 165562300
• Report Number: 2032493-2019-00260
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04987892098536
• UDI-Public: (01)04987892098536(11)190423(17)220331(10)19042358R
• Combination Product (y/n): N
• PMA/PMN Number: K173200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: MV-A6125ST
• Device Lot Number: 19042358R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention