MAUDE Adverse Event Report: CATHERA, INC. CATHERA; CATHETER, CONTINUOUS FLUSH

Model Number FG19120-1030-1S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 03/02/2018

Event Type  Injury  

Manufacturer Narrative

The device was discarded at the site.Attempts have been made to obtain additional information, however, our attempts have been unsuccessful.As the device was not returned, we are unable to perform further root cause analysis.Linked events: 2029214-2018-00233.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that post pipeline implantation, the patient experienced symptoms of a stroke.During the treatment of recurrent wide necked aneurysm.The procedure was completed with 80cm shuttle, phenom plus and phenom microcatheter.Vessel tortuosity was minimal (access was not complicated).Procedure went well - pipeline was placed in m1 and deployed through bifurcation into internal carotid artery (ica) and over the neck of aneurysm.Everything looked fine, but after procedure patient seemed to have symptoms of a stroke.Physician re-visit the images of the procedure and noted a haze (entangled lucency) around phenom plus catheter.Patient was taken for a thrombectomy, but there was no definite clot and she seemed to improve slightly.Definite hits on ct (distal brain), but symptoms improved.Still mild speech issue.The catheters were flushed and used as indicated in the ifu.The access vessel diameter was 4.5 mm.

• Brand Name: CATHERA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): CATHERA, INC.; 627 national ave; mountain view CA 94043
• Manufacturer (Section G): CATHERA, INC.; 627 national ave; mountain view CA 94043
• Manufacturer Contact: tricha miles ; 627 national ave.; mountain view, CA 94043 ; 9492753836
• MDR Report Key: 7375821
• MDR Text Key: 103649029
• Report Number: 3012113714-2018-00001
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: D260458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: FG19120-1030-1S
• Device Lot Number: AP17-063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2017
• 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): Other