MAUDE Adverse Event Report: MICROVENTION, INC. VIA 17 MICROCATHETER; PERCUTANEOUS CATHETER

Model Number	VIA-17-154-90-MVI2
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance's 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 product has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that after the web device was delivered using the via 17 through a sofia 6f 125cm and synchro 14 wire, the physician pulled the via 17 catheter out and the end of the catheter detached.There was no reported patient injury and the patient was reported to be doing fine.
Additional Manufacturer Narrative
The reported complaint is confirmed.Investigation found damage along the shaft of the catheter as well as the distal section separated from the proximal section, consistent with the alleged product issue.The damage identified on the catheter is consistent with the device experiencing forces over specification.The device was functioning as intended during the procedure as it was able to successfully implant a web device but was received in a nonfunctioning state that could not be used to implant a web device.This means that the damage happened after the implantation of the web but could not be fully determined as the sofia 6f and synchro 14 guidewire used during the procedure were not returned; thus, the interaction between the original sofia 6f, synchro 14 guidewire, and the via 17 could not be accessed.

• Brand Name: VIA 17 MICROCATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14246817
• Report Number: 2032493-2022-00175
• Device Sequence Number: 14713300
• Product Code: DQY
• UDI-Device Identifier: 00842429106457
• UDI-Public: (01)00842429106457(11)211027(17)240930(10)0000103725
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2022

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: 09/30/2024
• Device Model Number: VIA-17-154-90-MVI2
• Device Catalogue Number: VIA-17-154-90
• Device Lot Number: 0000103725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• 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