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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN VENOGRAM BALLOON CATHETER; CATHETER, FLOW DIRECTED
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MEDTRONIC, INC. ATTAIN VENOGRAM BALLOON CATHETER; CATHETER, FLOW DIRECTED Back to Search Results
Model Number 6215
Device Problem Deflation Problem (1149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2016
Event Type  malfunction  
Manufacturer Narrative
Product event summary - the balloon catheter was returned and analyzed and no anomalies were found.
 
Event 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.
 
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Brand Name
ATTAIN VENOGRAM BALLOON CATHETER
Type of Device
CATHETER, FLOW DIRECTED
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6321030
MDR Text Key67162914
Report Number2182208-2017-00310
Device Sequence Number1
Product Code DYG
UDI-Device Identifier00613994842114
UDI-Public00613994842114
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K012225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 12/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator 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
Date Manufacturer Received12/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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