VWING VASCULAR NEEDLE GUIDE, 6MM X 7MM 00144

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-05 for VWING VASCULAR NEEDLE GUIDE, 6MM X 7MM 00144 manufactured by Vital Access Corporation.

Event Text Entries

[4462781] (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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009273792-2014-00001
MDR Report Key3863000
Report Source05
Date Received2014-06-05
Date of Report2014-05-23
Date of Event2014-04-17
Date Mfgr Received2014-04-23
Device Manufacturer Date2013-10-09
Date Added to Maude2014-06-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactCHRISTOPHER PHILLIPS
Manufacturer Street2302 PRESIDENTS DR STE C
Manufacturer CitySALT LAKE CITY UT 841200000
Manufacturer CountryUS
Manufacturer Postal841200000
Manufacturer Phone8014339390
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVWING VASCULAR NEEDLE GUIDE, 6MM X 7MM
Generic NameVWING
Product CodePFH
Date Received2014-06-05
Model Number00144
Catalog Number00144
Lot Number13/0127
Device Expiration Date2015-09-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVITAL ACCESS CORPORATION
Manufacturer AddressSALT LAKE CITY UT US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2014-06-05

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