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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASONOVA INC. VASONOVA VASCULAR POSITIONING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR
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VASONOVA INC. VASONOVA VASCULAR POSITIONING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Catalog Number VSNCSPCW3A
Device Problem False Device Output (1226)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2014
Event Type  malfunction  
Event Description
It was reported the procedure was being performed in the icu/burn unit.The clinicians experienced a high catheter placement with a seasoned vps user.There was a proximal to mid catheter placement with a sustained blue bullseye.Chest x-ray was taken and confirmed high placement.As a result, the catheter was advanced further into the patient.There was a delay in treatment with no patient harm and no patient death or complications reported.It was noted the patient had normal sinus rhythm.
 
Manufacturer Narrative
Complaint no.(b)(4).
 
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Brand Name
VASONOVA 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 Key3994776
MDR Text Key4824247
Report Number3006795936-2014-00014
Device Sequence Number1
Product Code OBJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103260
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberVSNCSPCW3A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/15/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/01/2013
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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