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

Model Number	Q3-36163
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient arrived with a cta showing a left m2 occlusion.Iv thrombolytic was administered.Angiogram demonstrated the clot migrated to m3.Neuron max, phenom 27, aristole 18 and q catheter was used for aspiration.A q4 catheter was used first.The q4 catheter appeared to be oversized.As the microsystem was removed, the q4 prolapsed to main branch and lurched forward.Aspiration was performed in the main trunk.The q4 catheter was replaced with q3 catheter.Due to patient movement a new dsa was required.An angiogram was performed through the q3 catheter.The angiogram pushed contrast into the infarcted area.Patient had a hemorrhagic conversion due to forceful injection.The conversion requiring hemicraniectomy after the procedure.Patient showed functional recovery.

• Brand Name: MIVI Q DISTAL ACCESS CATHETER
• Common Device Name: DISTAL ACCESS CATHETER
• Manufacturer (Section D): MIVI NEUROSCIENCE, INC.; 6545 citywest parkway; eden prairie MN 55344
• Manufacturer (Section G): MIVI NEUROSCIENCE, INC.; 6545 citywest parkway; eden prairie MN 55344
• Manufacturer Contact: srija bandari ; 6545 citywest parkway; eden prairie, MN 55344 ; 9522081035
• MDR Report Key: 15759928
• Report Number: 3011410509-2022-00001
• Device Sequence Number: 6238633
• Product Code: DQY
• UDI-Device Identifier: B293Q3361630
• UDI-Public: B293Q3361630
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Q3-36163
• Device Catalogue Number: Q3-36163
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown