MAUDE Adverse Event Report: SEQUENT MEDICAL VIA 17 MICROCATHETER; CONTINUOUS FLUSH CATHETER

Model Number VIA-17-154-01

Device Problem Positioning Problem (3009)

Patient Problems Death (1802); Intracranial Hemorrhage (1891)

Event Date 03/13/2018

Event Type  Death  

Event Description

During the procedure the microcatheter via 17 could only be placed with huge difficulties within the aneurysm sack due to the location at the junction of basilar artery, posterior cerebral artery and superior cerbral artery.While advancing the web-device, delivered through a via 17, the microcatheter could not be kept accurate in a optimal position for a good deployment of the device.While manipulating the overall system to achieve a perfect placement of the web, either the tip of the microcatheter or the distal tip of the partially deployed web device perforated the aneurysm and caused bleeding.Aneurysm ruptured and caused bleeding for approximately 15 minutes while the bleeding could be stopped through implanting 4 coils.

• Brand Name: VIA 17 MICROCATHETER
• Type of Device: CONTINUOUS FLUSH CATHETER
• Manufacturer (Section D): SEQUENT MEDICAL; 11 columbia; aliso viejo CA 92656
• Manufacturer (Section G): SEQUENT MEDICAL; 11 columbia; aliso viejo CA 92656
• Manufacturer Contact: curtis hanson ; 11 columbia; aliso viejo, CA 92656 ; 9498309600
• MDR Report Key: 7447719
• MDR Text Key: 106075503
• Report Number: 3008423090-2018-00001
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162565
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: VIA-17-154-01
• Device Catalogue Number: FG17154-01
• Device Lot Number: 17102703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2017
• 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
• Patient Outcome(s): Death