MAUDE Adverse Event Report: SEQUENT MEDICAL INC VIA 27 MICROCATHETER; CONTINUOUS FLUSH CATHETER

Model Number VIA-27-154-01

Device Problem Positioning Problem (3009)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 01/11/2017

Event Type  Injury  

Event Description

The physician had chosen to web an elective un-ruptured icat and a second physician was proctoring the case.The second physician phoned me after the case and explained that once the web had been partially opened they decided to re-sheath.When they were re-sheathing the via moved forwards and went through the wall of the aneurysm.It was a large hole and led to a severe major bleed.They then decided to remove the via and web, put a balloon up and coil the aneurysm.This is the same event as (b)(4).The patient from wednesday is recovering slowly.Coils were placed in the ruptured aneurysm to stabilize it.Patient sent to surgery to release pressure from the bleed.The patient remains very poorly and the hospital physician does not hold much hope for a good outcome.

• Brand Name: VIA 27 MICROCATHETER
• Type of Device: CONTINUOUS FLUSH CATHETER
• Manufacturer (Section D): SEQUENT MEDICAL INC; sequent medical inc; 11a columbia; aliso viejo CA 92656
• Manufacturer (Section G): SEQUENT MEDICAL INC.; 11a columbia; aliso viejo CA 92656
• Manufacturer Contact: curtis hanson ; 11a columbia; aliso viejo, CA 92656 ; 9498309600
• MDR Report Key: 6311731
• MDR Text Key: 66815291
• Report Number: 3008423090-2017-00001
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2017,02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: VIA-27-154-01
• Device Catalogue Number: FG27154-01
• Device Lot Number: 16111706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/11/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2017
• Date Manufacturer Received: 01/11/2017
• Date Device Manufactured: 11/01/2016
• 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: (B)(4)
• Patient Outcome(s): Hospitalization
• Patient Age: 46 YR