MAUDE Adverse Event Report: MIVI NEUROSCIENCE, INC. MIVI Q CATHETER; DISTAL ACCESS CATHETER

Model Number	Q6-69145
Medical Device Problem Codes	Off-Label Use (1494); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A 75-year-old male patient presented with a left superior division m2 occlusion.Patient underwent a thrombectomy procedure in left m2 where the q6 catheter was used with neuron max long sheath, prowler microcatheter, synchro guidewire, solitaire stent retriever and penumbra engine.Neuron max placed in left ica.Large cervical carotid artery aneurysm that was in the mid to distal cervical carotid artery & neuron max placed in that aneurysm.When advanced the q6 catheter to the mca occlusion, it was over a prowler microcatheter & synchro guidewire.Once microcatheter passed the clot, physician deployed solitaire sr, and while he let it dwell inside the clot, he noticed that the catheter started to flow up the mca.Catheter had become detached from the pusher wire.He tried to pull the stent retriever and capture the catheter, but he was unable to - stent retriever went through detached catheter.Tried a snared balloon to capture the catheter but was unsuccessful.Stopped procedure & called vascular surgery, who removed the catheter from the ica surgically.Patient's deficits remained stable, no neurological worsening from the initial clinical presentation.No vessel injury noted, and patient discharged to skilled nursing facility with mild right sided weakness, with aphasia consistent with initial clinical presentation.

• Brand Name: MIVI Q CATHETER
• Common Device Name: DISTAL ACCESS CATHETER
• Manufacturer (Section D): MIVI NEUROSCIENCE, INC.; 6545 city west parkway; eden prairie 55344
• Manufacturer (Section G): MIVI NEUROSCIENCE, INC.; 6545 city west parkway; eden prairie 55344
• Manufacturer Contact: srija bandari ; 6545 city west parkway; eden prairie 55344 ; 6124472897
• MDR Report Key: 17577075
• Report Number: 3011410509-2023-00003
• Device Sequence Number: 18381861
• Product Code: DQY
• UDI-Device Identifier: B293Q6691450
• UDI-Public: B293Q6691450
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K192558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2024
• Device Model Number: Q6-69145
• Device Catalogue Number: Q6-69145
• Device Lot Number: M23010001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male