MAUDE Adverse Event Report: MICROVENTION, INC. VIA-27 MICROCATHETER; PERCUTANEOUS CATHETER

Model Number	FG27154-01
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
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.The investigation of the returned via microcatheter found extensive damage, missing coating, and a flared distal tip.Functional testing with the returned web device and the via 27 resulted in unsuccessful retraction; however, the web device was able to resheath successfully into an in-house via 27.The failed retraction with the returned unit during lab testing was determined to be related to the flared distal tip and damaged areas found on the via 27 microcatheter; however, this evaluation could not determine if this damage was present at the time the original failure to resheath completely occurred.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.
Event or Problem Description
It was reported that a web device was used to treat a wide-necked basilar tip aneurysm.A via 27 placed into aneurysm.A web was deployed successfully on first attempt into aneurysm; however, a decision was taken to change the size.The original web was resheathed; however, friction was encountered.The partially deployed web/via system was withdrawn into a guide catheter and removed from the patient.A new via 27 microcatheter was taken and placed in the aneurysm, a web was successfully deployed and implanted.On first inspection the via 27 had a split outer coating and intact inner catheter.There was no report of any coating parts left in the patient, and no report of harm or injury to the patient, who is doing well.

• Brand Name: VIA-27 MICROCATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12782807
• Report Number: 2032493-2021-00444
• Device Sequence Number: 12247901
• Product Code: DQY
• UDI-Device Identifier: 00851566003420
• UDI-Public: (01)00851566003420(11)191014(17)220930(10)19101402
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: FG27154-01
• Device Catalogue Number: FG27154-01
• Device Lot Number: 19101402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• 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: Female