MAUDE Adverse Event Report: MIVI NEUROSCIENCE, INC. MODEL Q6-69145; Q6 DISTAL ACCESS CATHETER

Model Number	Q6-69145
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Infarction, Cerebral (1771)
Date of Event	05/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned q6 device was received in two (2) separate pieces fully traceable with mivi lot number.No additional components were received for analysis.Distal shaft appeared normal, distal end not damaged, proximal edge (where catheter segment and push wire attach) was split and displayed physical damage.Based on device analysis and type of damage, the most likely scenario for the push wire detachment is that the proximal edge of the q6 tubular segment either interacted with just the distal tip of the guide catheter or with the distal tip of the guide catheter in conjunction with a guidewire.This interaction caused damage resulting in a separation of the push wire from the tubular segment.The type of damage is indicative of the device being retracted while experiencing excessive resistance.Accessory devices were not returned for analysis.Manufacturing records for the device lot did not reveal any outstanding discrepancies, design, or quality records issues.(b)(4).
Event or Problem Description
It was reported that during a stroke procedure the q catheter was used but complete revascularization was not achieved.The q catheter was reintroduced into the vasculature, upon retraction resistance was felt.The catheter was forcible retracted and separated into two pieces with one piece remaining in the patients body.Attempts made to snare the piece were unsuccessful.Detached segment was successfully retrieved during carotid endarterectomy.

• Brand Name: MODEL Q6-69145
• Common Device Name: Q6 DISTAL ACCESS CATHETER
• Manufacturer (Section D): MIVI NEUROSCIENCE, INC.; 6545 city west parkway; eden prairie MN 55344
• MDR Report Key: 8740940
• Report Number: 3011410509-2019-00002
• Device Sequence Number: 13963077
• 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: K163233
• Number of Events Summarized: 1
• Summary Report (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): 06/20/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2019
• Device Model Number: Q6-69145
• Device Catalogue Number: Q6-69145
• Device Lot Number: M19010002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention