MAUDE Adverse Event Report: MIVI NEUROSCIENCE, INC. Q6 ASPIRATION CATHETER

Model Number Q6-69145-E

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Infarction, Cerebral (1771)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

The device was received in two pieces.Upon visual inspection, device was separated at the proximal edge of the catheter at the attachment between the catheter and the push wire.The proximal edge of the catheter displayed physical damage where the push wire was attached.This type of damage can occur as a result of forcefully retracting the q catheter against resistance.It is possible the q6 catheter interacted with the sheath while attempting to forcibly retract it and the device separated.Accessory devices were not returned for analysis.Manufacturing records for the device lot were reviewed and did not reveal any outstanding discrepancies, design, or quality records.This device is a ce marked device distributed only in the eu.

Event Description

The patient was undergoing a thrombectomy procedure using the q6 aspiration catheter (q6-69145-e).During the procedure the physician noticed the proximal marker band of the q catheter had been extended past the distal marker band of the guide catheter.The physician attempted to retract the q6 into the guide catheter but was unsuccessful.The physician then attempted to remove the q6 and the catheter together through the sheath.During the removal, the q6 catheter separated with the wire portion in the sheath.The physician used a snare device to successfully remove the detached catheter portion of the q6.The thrombectomy procedure was completed.There was no reported patient injury.

• Brand Name: Q6 ASPIRATION CATHETER
• Type of Device: Q6 ASPIRATION CATHETER
• Manufacturer (Section D): MIVI NEUROSCIENCE, INC.; 6545 city west parkway; eden prairie MN 55344
• Manufacturer (Section G): MIVI NEUROSCIENCE, INC.; 6545 city west parkway; eden prairie MN 55344
• Manufacturer Contact: randy labounty ; 6545 city west parkway; eden prairie, MN 55344 ; 9529443834
• MDR Report Key: 8506116
• MDR Text Key: 141724503
• Report Number: 3011410509-2019-00001
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2019

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: 11/06/2019
• Device Model Number: Q6-69145-E
• Device Catalogue Number: Q6-69145-E
• Device Lot Number: M18120007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2018
• 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): Required Intervention