MAUDE Adverse Event Report: VASONOVA INC. FLYBOOK CONSOLE WITH PRINTER; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number VSNCS[CW3A]

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2013

Event Type  malfunction  

Event Description

It is reported this event occurred on a female patient with the insertion site being the right arm.While accessing the patient using the flybook console, the clinician had concern over which vessel was the artery and which was the vein because they were extremely close together.She stuck what she believed was the vein, having the confidence to move forward with the procedure because she was using vps.The case, in her estimation, was fairly standard after the initial stick and vps showed a green arrow until a blue bulls-eye was obtained.However, during the post-insertion chest x-ray process, the radiologists couldn't confirm whether the picc was in the svc or in an artery.Still feeling uneasy, blood gases were drawn via respiratory therapy.The readings were consistent with an artery stick.The picc was removed and replaced.The second picc was confirmed as accurately placed by the radiology group.

Manufacturer Narrative

(b)(4).

• Brand Name: FLYBOOK CONSOLE WITH PRINTER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VASONOVA INC.; menlo park CA
• Manufacturer Contact: jody cadd, sr ; 155 jefferson drive; suite 100; menlo park, CA 94025-0000 ; 6103780131
• MDR Report Key: 3640019
• MDR Text Key: 4208718
• Report Number: 3006795936-2014-00001
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103260
• 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: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VSNCS[CW3A]
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1