VWING VASCULAR NEEDLE GUIDE
Received Mar 24, 2016 · Event occurred Nov 18, 2015
Report 3009273792-2015-00002 · MDR key 5522440
Device
Product problems
- Insufficient Device Problem Information
Patient
43 YR
- Purulent Discharge
- Pneumonia
- Purulent Discharge
- Pneumonia
Narrative
Additional 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.
Description of Event or Problem
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.
Additional Manufacturer Narrative
STILL IMPLANTED - REMOVAL SCHEDULED.
Description of Event or Problem
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.