Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VITAL ACCESS SYSTEMS VWING; VASCULAR NEEDLE GUIDE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VITAL ACCESS SYSTEMS VWING; VASCULAR NEEDLE GUIDE Back to Search Results
Model Number 00171
Device Problems Gradient Increase (1270); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)
Patient Problems Therapeutic Effects, Unexpected (2099); Stenosis (2263)
Event Date 03/08/2014
Event Type  Injury  
Event Description
Pt received implantation of 2 venous window needle guides as part of a clinical trial on (b)(6) 2012.They were successfully used for hemodialysis.The pt experienced a drop in intra-access fistula flow that was noticed on (b)(6) 2014.She underwent a fistulogram on (b)(6) 2014.The fistulogram showed a 90% stenosis of the fistula right at the downstream end of the venous window needle guide as well as other stenoses closer to the arteriovenous anastamosis.The stenoses were treated with 8mm balloon angioplasty and the flow was improved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VWING
Type of Device
VASCULAR NEEDLE GUIDE
Manufacturer (Section D)
VITAL ACCESS SYSTEMS
2302 s. presidents dr.
suite # c
salt lake city UT 84120
MDR Report Key3792910
MDR Text Key21875355
Report Number3792910
Device Sequence Number1
Product Code PFH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 03/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number00171
Device Lot Number11-0093
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/09/2014
Distributor Facility Aware Date03/08/2014
Device Age1 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/09/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age71 YR
-
-