MAUDE Adverse Event Report: MICROVENTION, INC. VIA-33 MICROCATHETER; PERCUTANEOUS CATHETER

Model Number	FG33133-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Two dsa images were provided for review, which are of poor radiographic quality.A small radiopaque object is visible in the dome of the aneurysm.It is possible that the object represents a catheter marker as described in the reported details; however, it cannot be conclusively determined.The product had been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during a web embolization procedure to treat a basilar apex aneurysm in a tortuous vertebral artery, the via met resistance during advancement through the guide catheter.After removal, the distal marker band of the via was identified in the aneurysm.The web device was implanted as planned without incident, capturing the marker band in the dome of the aneurysm.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
A split section near the distal tip of the microcatheter was found during the investigation.The distal tip marker band was not attached nor returned for evaluation.The conditions or circumstances that led to the damage could not be determined, but the damage is consistent with the device experiencing excessive forces beyond its specifications.

• Brand Name: VIA-33 MICROCATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11061232
• Report Number: 2032493-2020-00382
• Device Sequence Number: 2610388
• Product Code: DQY
• UDI-Device Identifier: 00851566003703
• UDI-Public: (01)00851566003703(11)190528(17)220630(10)19052802
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: FG33133-01
• Device Catalogue Number: FG33133-01
• Device Lot Number: 19052802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR