MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY DUO MICROCATHETER; DIAGNOSTIC INTRAVASCULAR CATHETER

Model Number MC162156S

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

Patient Problems Hemorrhage, Cerebral (1889); Rupture (2208)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided.A search for non-conformances associated with the device's part/lot number combination could not be conducted.The device was not returned to the manufacturer.The root cause could not be determined.The instructions for use (ifu) identifies vessel or aneurysm perforation and intracerebral/intracranial hemorrhage as potential complications associated with use of the device.

Event Description

It was reported that during the attempt to access an aneurysm with the microcatheter and a guide wire (not a microvention device), the aneurysm ruptured and extravasation was observed.The aneurysm was then coiled, as planned.There was no reported sequela as a result of the rupture.

• Brand Name: HEADWAY DUO MICROCATHETER
• Type of Device: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10226423
• MDR Text Key: 197560294
• Report Number: 2032493-2020-00154
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MC162156S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening