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

Model Number	VIA-27-154-01-MVI2
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Headache (1880); Hemorrhage/Blood Loss/Bleeding (1888); Ruptured Aneurysm (4436)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when advancing a web device through the via 27 during the treatment of an anterior communicating artery (acom) aneurysm, the via catheter shifted forward and perforated the dome of the aneurysm, resulting in bleeding into the brain.The via and web device were removed, and the ruptured aneurysm was treated with coils.The patient was being monitored in the icu and reported to be neurologically intact and had a headache.There were no focal deficits or hydrocephalus, and the blood is clearing up on ct head.
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 device was discarded at the user facility and not returned to the manufacturer for evaluation.Procedural or medical imaging was requested and not provided.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The event as described could not be confirmed.If imaging is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies aneurysm rupture as a potential complication associated with the use of the device.

• 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; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15556223
• Report Number: 2032493-2022-00370
• Device Sequence Number: 5746605
• Product Code: DQY
• UDI-Device Identifier: 00842429106426
• UDI-Public: (01)00842429106426(11)220607(17)250531(10)0000197935
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: VIA-27-154-01-MVI2
• Device Catalogue Number: VIA-27-154-01
• Device Lot Number: 0000197935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female