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 04/22/2014

Event Type  malfunction  

Event Description

It was reported the catheter was being placed for the patient in their room.They were using the biosensor with a bard 6fr power picc solo.An experienced picc nurse was placing the catheter with the use of the vps and had excellent doppler flow.The anti-grade flow signature was seen as well as the hear valves were clearly audible.The case ended on a steady blue bulls eye.A chest x-ray was performed and revealed the catheter tip was in the contra-lateral internal jugular.The patient was sent to interventional radiology to have the catheter repositioned.It was noted they were using a vps7220b from lot 19f13l0037.They also noted they have done approximately 30 to 40 cases and have had great success blue bulls eyes and non-blue bulls eye cases.There was no delay in therapy and 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 000
• Manufacturer Contact: jody cadd, sr., specialist ; 2400 bernville road; suite 100; reading, CA 19605-0000 ; 6103780131
• MDR Report Key: 3972911
• MDR Text Key: 4635065
• Report Number: 3006795936-2014-00007
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• 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
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VPS7220B BIOSENSOR, BARD 6 FR POWER PICC SOLO