FDA.reportPublic FDA data

MAUDE MDR 5522103

MDR report key
5522103
Report number
3009273792-2016-00001
Event key
0
Event type
3
Date of event
2016-01-03
Date received
2016-03-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MARK CRAWFORD
Address
448 E. WINCHESTER ST. SUITE 250 SALT LAKE CITY UT 84107 US
Phone
801-801-8014
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VWING VASCULAR NEEDLE GUIDEVWING VASCULAR NEEDLE GUIDEVITAL ACCESS CORP.PFHR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-2401. H; 2. L; 3. R

Event Narratives#

N

Patient 1

INITIALLY SUBMITTED TO FDA ON 05 FEBRUARY 2016 AS 2009273792-2016-00001, INSTEAD OF 3009273792-2016-00001. AMENDED REPORT WITH CORRECT FEI NUMBER (3009273792) SUBMITTED ON 23 MARCH 2016. INFECTED DEVICE - EVALUATED AT HOSPITAL.

D

Patient 1

PT PRESENTED TO ER WITH INFECTED AVF ((B)(6) 2016). REDNESS, SWELLING, HEAVY DISCHARGE, PAIN FOR PAST 2 DAYS. SHE SAID THE PAIN AND DRAINAGE STARTED A LITTLE WHILE AFTER DIALYSIS HAD ACCESSED THE FISTULA. IT GOT PROGRESSIVELY WORSE UNTIL SHE PRESENTED TO ER. BLOOD CULTURES POSITIVE. SHE WAS TAKEN TO SURGERY THE NEXT DAY AND THE LOWER (ARTERIAL) V-WING WAS REMOVED, SENT TO PATHOLOGY. IT TESTED (B)(6), AS DID THE BLOOD CULTURES. SHE IS STILL HOSPITALIZED. BEING TREATED WITH VANCOMYCIN, FLAGYL, MEROPENEM, AND CIPRO. HAS SINCE DEVELOPED C. DIFF AND GETS A LITTLE MORE CONFUSED EVERY DAY, THOUGH CT AND MRI OF BRAIN ARE NEGATIVE FOR ISCHEMIA. THEY HAVE NOT BEEN ABLE TO ACCESS THE AVF SUCCESSFULLY YET. CURRENTLY DIALYZING THROUGH FEMORAL ACCESS. AVF HAS PALPABLE THRILL AND BRUIT AUDIBLE, BUT STILL HAVE BEEN UNSUCCESSFUL AT CANNULATING.