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

Model Number	Q6-69145
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During a stroke thrombectomy procedure, the physician advanced the q6 catheter to m1 clot with a 3max and aspirated the clot.The clot was retrieved, and the patient was ready for an angiogram.Physician noticed the marker band after performing the angiogram.After several attempts to retrieve the marker band in the sheath it escaped and lodged back in the m1.The patient had tici 3 and the physician opted to leave the marker band as acutely it was not affecting flow.

• Brand Name: MIVI Q CATHETER
• Common Device Name: DISTAL ACCESS 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: srija bandari ; 6545 city west parkway; eden prairie, MN 55344 ; 9529443438
• MDR Report Key: 16930548
• Report Number: 3011410509-2023-00002
• Device Sequence Number: 15154819
• Product Code: DQY
• UDI-Device Identifier: B293Q6691450
• UDI-Public: B293Q6691450
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/15/2023

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 Model Number: Q6-69145
• Device Catalogue Number: Q6-69145
• Device Lot Number: NOT KNOWN
• 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: 04/19/2023
• Initial Report FDA Received Date: 05/15/2023
• 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
• Patient Sex: Unknown