MAUDE Adverse Event Report: VASONOVA INC VASCULAR POSITIONING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number VPS-G4C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

It was reported the catheter was placed into the left subclavian vein of the patient in the micu.The clinician received a steady blue bullseye during placement.The patient then needed a shiley catheter placed on the right side.The shiley was a difficult insertion and they could not obtain a blue bullseye because of the difficult vasculature and insertion.The clinician had a stat chest x-ray taken to see where the shiley catheter tip was to determine his next troubleshooting steps and to complete the procedure.It was on this subsequent chest x-ray that the clinician saw his primary line, the triple lumen catheter malpositioned.The radiologist stated that the catheter tip looked to be in the left innominate vein.They do not know if this caused a delay in treatment and there was no patient death or complications reported.

Manufacturer Narrative

(b)(4).

• Brand Name: VASCULAR POSITIONING SYSTEM
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VASONOVA INC; menlo park CA
• Manufacturer (Section G): VASONOVA INC.; 155 jefferson drive; suite 100; menlo park CA 94025
• Manufacturer Contact: jody cadd, sr, ras ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 3894358
• MDR Text Key: 4539988
• Report Number: 3006795936-2014-00002
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K12381317
• 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: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VPS-G4C
• 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
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1