MAUDE Adverse Event Report: SEQUENT MEDICAL INC., ALISO VIEJO, CA VIA 27 MICROCATHETER; CONTINUOUS FLUSH CATHETER

Model Number VIA 27-154-01

Device Problem Positioning Problem (3009)

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

Event Date 09/20/2017

Event Type  Death  

Event Description

The microcatheter via 27 was delivered into the aneurysm sack at the acom.As the web-device was advanced through the microcatheter, suddenly the distal tip of the microcatheter moved forward and perforated the aneurysm dome.The constrained web device within the microcatheter at this time has been around the a1 segment.The microcatheter and the whole tri-axial catheter system has been brought back in right position.Delivery of the web device has been continued.After unsheathing the web and having it properly opened in right position control angiogram has been performed, showing bleeding out of the aneurysm sack.Decision to detach the web has been made and detachment has been performed properly without any problems.At this stage of the procedure numerous attempts to stop the bleeding has been performed: using 2 scepter occlusion balloons, filling spaces around the implant with onyx, coiling at the residual neck proximal of the web 2 evd as emergency rescue activity has been performed in angio suite by neurosurgery team.Sequent personnel spoke with physicians after the case and discussed the difficult guidewire/catheter access of the aneurysm and subsequent build-up of tension in the micro-catheter system (neuronmax, cat 6f, via27) during web delivery (friction/resistance at the m1/a1 junction) that led to catheter movement and perforation.

• Brand Name: VIA 27 MICROCATHETER
• Type of Device: CONTINUOUS FLUSH CATHETER
• Manufacturer (Section D): SEQUENT MEDICAL INC., ALISO VIEJO, CA; 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: 6954846
• MDR Text Key: 89497010
• Report Number: 3008423090-2017-00002
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132652
• 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: 10/16/2017

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 Expiration Date: 05/31/2020
• Device Model Number: VIA 27-154-01
• Device Catalogue Number: FG27154-01
• Device Lot Number: 17050502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2017
• 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
• Patient Age: 68 YR