MAUDE Adverse Event Report: VASONOVA INC. VASCULAR POSITIONING SYSTEM; VPS G4 SYSTEM

Catalog Number VPS-G4C

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the catheter was being placed into the patient's basilic vein.During insertion, the stylet initially showed a green symbol when the clinician put it in the patient's arm.Flushing was obvious on the device.As she proceeded to insert the catheter, a continuous yellow symbol was present.She removed the stylet, ensured the stylet was visible, re-inserted and advanced the stylet when in the bloodstream and there was no change.The waveform was dampened by the clinician.The clinician completed the catheter placement with the navigator system to ensure it was heading down properly.There was no delay in treatment and no patient death or complications reported.It was noted a single packaged stylet was being used for the procedure.

Manufacturer Narrative

(b)(4).The reported event could not be confirmed through evaluation of the returned data set.The vps senior algorithm scientist concluded the provided data was for a different procedure from the reported event and a conclusion about what happened cannot be made.A device history record review for unit was performed and there were no relevant findings.The probable cause of this event is undetermined because the provided data was for a different procedure from the reported event.No further action will be taken.

• Brand Name: VASCULAR POSITIONING SYSTEM
• Type of Device: VPS G4 SYSTEM
• Manufacturer (Section D): VASONOVA INC.; menlo park CA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 2400 bernville road; reading PA 19605
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5358362
• MDR Text Key: 35610169
• Report Number: 2518433-2016-00003
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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