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

Model Number	FG27154-01
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
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 device has not been not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed at this time.
Event or Problem Description
It was reported that during a procedure for the treatment of a carotid siphon aneurysm with unfavorable anatomy, a web device failed placement and got stuck in the via 27 microcatheter.The physician decided to remove all the devices all at once.Reportedly, the via 27 was delaminated.The physician used a second via microcatheter and a second web and the procedure was successfully completed without any problem.
Additional Manufacturer Narrative
Summary device evaluation: the investigation of the returned via microcatheter found a bend 54.5cm from the end of the distal tip and a damaged delaminated section 1.2cm to 9.8cm from the end of the distal tip; furthermore, an in-house web experienced heavy resistance/friction at the site of the damaged delaminated section while attempting to advance through the microcatheter during functional testing, which is consistent with the alleged product issue.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 via-27 experiencing forces over specification during the attempt at removal as described in the reported complaint.The web and neuronmax catheter used in the procedure were not evaluated as a part of this evaluation, so the investigation could not determine if they had caused or contributed to the reported complaint.

• 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: 13587354
• Report Number: 2032493-2022-00067
• Device Sequence Number: 5681425
• 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: FR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WEB SL
• Patient Sex: Unknown