MAUDE Adverse Event Report: MICROVENTION, INC VIA-17 MICROCATHETER; CATHETER, CONTINUOUS FLUSH

Model Number VIA-17-154-45-MVI2

Device Problem Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); Ruptured Aneurysm (4436)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

A visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging were not provided for this investigation.Without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device's risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformance's.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.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 instructions for use (ifu) identifies aneurysm rupture as a potential complication associated with the use of the device.

Event Description

It was reported that when the physician was treating an aneurysm in the a1, the physician advanced the web device close to the tip of via-17 and the catheter jumped forward and ruptured the aneurysm.They deployed the device and utilized a scepter xc balloon to slow the bleeding.Bp remained stable at 84/49 during rupture.The procedure was successfully completed.Post-procedure, they transfused 6 units of platelets and maintained bp120.The patient was discharged several days later mostly due to underlying early dementia.

• Brand Name: VIA-17 MICROCATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16125563
• MDR Text Key: 306975223
• Report Number: 2032493-2023-00004
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00842429106440
• UDI-Public: (01)00842429106440(11)220817(17)250731(10)0000244630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: VIA-17-154-45-MVI2
• Device Catalogue Number: VIA-17-154-45
• Device Lot Number: 0000244630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCEPTER XC BALLOON
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female