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: MEDTRONIC, INC. ATTAIN VENOGRAM BALLOON CATHETER; CATHETER, FLOW DIRECTED
  • 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
 

MEDTRONIC, INC. ATTAIN VENOGRAM BALLOON CATHETER; CATHETER, FLOW DIRECTED Back to Search Results
Model Number 6215
Medical Device Problem Code Deflation Problem (1149)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/06/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product event summary - the balloon catheter was returned and analyzed and no anomalies were found.
 
Event or Problem Description
It was reported that during the implant procedure, the venogram balloon catheter did not inflate completely.The catheter also did not deflate completely.The catheter was not used and was replaced with a new balloon catheter.No patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATTAIN VENOGRAM BALLOON CATHETER
Common Device Name
CATHETER, FLOW DIRECTED
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key6321030
Report Number2182208-2017-00310
Device Sequence Number578279
Product Code DYG
UDI-Device Identifier00613994842114
UDI-Public00613994842114
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K012225
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date05/24/2018
Device Model Number6215
Device Catalogue Number6215
Device Lot Number61496285
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/07/2016
Initial Report FDA Received Date02/09/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-