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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VITAL ACCESS CORP. VWING VASCULAR NEEDLE GUIDE
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VITAL ACCESS CORP. VWING VASCULAR NEEDLE GUIDE Back to Search Results
Model Number 00146
Device Problem Insufficient Information (3190)
Patient Problems Purulent Discharge (1812); Pneumonia (2011)
Event Date 11/18/2015
Event Type  Injury  
Manufacturer Narrative
Still implanted - removal scheduled.
 
Event Description
Patient (b)(6) had a scab over their arterial access site, which showed pus once removed.A blood culture was negative, but a skin culture at the site showed klebsiella pneumoniae.Patient received antibiotics (ancef) but refused to receive a central venous catheter during healing.Cannulations of the patient's fistula are continuing outide of the vwing sites.Vwing devices are scheduled to be removed.
 
Manufacturer Narrative
Patient kw had a scab over their arterial access site, which showed pus once removed.A blood culture was (b)(6), but a skin culture at the site showed klebsiella pneumoniae.Patient received antibiotics (ancef) but refused to receive a central venous catheter during healing.Cannulations of the patient's fistula are continuing outside of the vwing sites.Initially, the company was informed that the vwing devices were scheduled to be removed.Upon seeing the patient, the implanting surgeon was able to further diagnose the patient.While the patient did have a cannulation-related infection, this infection was determined to be separate from the vwing devices.The patient was diagnosed with an infected hematoma.The vwing devices were both left in place in the patient while the hematoma healed.The company has been informed that the patient is now being cannulated successfully through their vwing devices again.No vwing-related serious adverse event occurred.Devices not removed - not infected.
 
Event Description
Patient kw had a scab over their arterial access site, which showed pus once removed.A blood culture was (b)(6), but a skin culture at the site showed klebsiella pneumoniae.Patient received antibiotics (ancef) but refused to receive a central venous catheter during healing.Cannulations of the patient's fistula are continuing outside of the vwing sites.Initially, the company was informed that the vwing devices were scheduled to be removed.Upon seeing the patient, the implanting surgeon was able to further diagnose the patient.While the patient did have a cannulation-related infection, this infection was determined to be separate from the vwing devices.The patient was diagnosed with an infected hematoma.The vwing devices were both left in place in the patient while the hematoma healed.The company has been informed that the patient is now being cannulated successfully through their vwing devices again.No vwing-related serious adverse event occurred.
 
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Brand Name
VWING VASCULAR NEEDLE GUIDE
Type of Device
VWING
Manufacturer (Section D)
VITAL ACCESS CORP.
448 e. winchester st.
suite 250
salt lake city UT 84107
Manufacturer (Section G)
VITAL ACCESS CORP.
448 e. winchester st.
suite 250
salt lake city UT 84107
Manufacturer Contact
mark crawford
448 e. winchester st.
suite 250
salt lake city, UT 84107
8014339390
MDR Report Key5522440
MDR Text Key41033514
Report Number3009273792-2015-00002
Device Sequence Number1
Product Code PFH
UDI-Device Identifier08199260101465
UDI-Public08199260101465
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date03/31/2020
Device Model Number00146
Device Lot Number15-0032
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age43 YR
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