• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAPHEON / MEDTRONIC VENASEAL CLOSURE SYSTEM-CE MARK AGENT, OCCLUDING, VASCULAR, PERMANENT

  • 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
 

SAPHEON / MEDTRONIC VENASEAL CLOSURE SYSTEM-CE MARK AGENT, OCCLUDING, VASCULAR, PERMANENT Back to Search Results
Model Number SP-101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/09/2015
Event Type  Injury  
Event Description

Procedure was performed in (b)(6). Customer stated that a patient contacted his facility on (b)(6) 2015, to ask if there have been any reports of acute psychosis in post venaseal treatments. Patient treated with venaseal has been referred for psychiatric evaluation due to extreme euphoria post treatment. After further investigation, the patient was diagnosed with bipolar affective disorder. His post procedure duplex scan demonstrates and excellent result with closurefast cather from 3cm beyond the junction bilaterally with no evidence of dvt.

 
Manufacturer Narrative

A review of the manufacturing records for this device did not reveal any discrepancies relevant to the reported event. Additional information has been requested, should it become available a supplemental report will be submitted. (b)(4). Results: adhesive.

 
Manufacturer Narrative

(b)(6). Customer stated that a patient contacted his facility on (b)(6) 2015, to ask if there have been any reports of acute psychosis in post venaseal treatments. Patient treated with venaseal has been referred for psychiatric evaluation due to extreme euphoria post treatment. After further investigation, the patient was diagnosed with bipolar affective disorder. His post procedure duplex scan demonstrates and excellent result with venaseal closure system from 3cm beyond the junction bilaterally with no evidence of dvt.

 
Manufacturer Narrative

This mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.   a capa has been opened to manage the actins related to remediation of complaint files and any required mdr reporting.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENASEAL CLOSURE SYSTEM-CE MARK
Type of DeviceAGENT, OCCLUDING, VASCULAR, PERMANENT
Manufacturer (Section D)
SAPHEON / MEDTRONIC
951 aviation parkway
morrisville NC 27560
Manufacturer (Section G)
SAPHEON/MEDTRONIC
951 aviation parkway
morrisville NC 27560
Manufacturer Contact
33987000
MDR Report Key4841327
Report Number3011410703-2015-00004
Device Sequence Number1
Product CodePJQ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/12/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/01/2016
Device MODEL NumberSP-101
Device Catalogue NumberSP-101
Device LOT Number38407
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/12/2015 Patient Sequence Number: 1
-
-