MAUDE MDR 3863000

MDR report key
3863000
Report number
3009273792-2014-00001
Event key
0
Event type
3
Date of event
2014-04-17
Date received
2014-06-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CHRISTOPHER PHILLIPS
Address
2302 PRESIDENTS DR STE C SALT LAKE CITY UT 84120 US
Phone
801-801-8014
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VWING VASCULAR NEEDLE GUIDE, 6MM X 7MMVWINGVITAL ACCESS CORPORATIONPFH001440014413/0127R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-06-0501. H; 2. R

Event Narratives#

D

Patient 1

(B)(6) HAD TWO VWING DEVICES IMPLANTED ON A LEFT UPPER ARM BRACHIOCEPHALIC FISTULA ON (B)(6) 2014. HER VWING SITES WERE INITIALLY USED TO ACCESS HER BRACHIOCEPHALIC FISTULA ON (B)(6) 2014. CANNULATIONS CONTINUED WITH A FREQUENCY OF THREE TIMES PER WEEK UNTIL THE EVENT. ON PHYSICAL EXAMINATION, THE SITES HAD A 'FAIR AMOUNT OF REDNESS AND ALSO WARMTH'. AFTER ANGIOGRAPHY, PUS WAS 'EASILY ABLE TO BE REMOVED FROM A NEEDLE CANNULATION SITE. THEREFORE, THE VWINGS WERE REMOVED'. DURING REMOVAL OF THE DEVICES, THE DISTAL VWING WAS OBSERVED TO HAVE 'PUS WITHIN THE FLUTED AREA. THERE WAS A HEMATOMA THERE AND ALSO ONCE THE VWING WAS MOBILIZED THERE WAS A VERY LARGE DEFECT' IN THE VESSEL WALL. DUE TO THE LOSS OF VASCULAR INTEGRITY, THE FISTULA WAS LIGATED NEAR THE ELBOW. THE SITES WERE COPIOUSLY IRRIGATED AND DRIED. THE VWINGS WERE REMOVED COMPLETELY AND THE WOUND WAS PACKED WITH IODOFORM GAUZE'. THE WOUND SITES WERE CULTURED AND WERE DETERMINED AND TO BE A LOCALIZED (B)(6) INFECTION. NO BLOODSTREAM INFECTION OR SEPSIS HAD OCCURRED. NS WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY ON (B)(6) 2014. SHE IS CURRENTLY DIALYZING USING A CENTRAL VENOUS CATHETER.