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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
Medical Device Problem Code Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/19/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product event summary: the balloon catheter was returned and analyzed.No anomalies were found.The analyst noted a test guidewire was fully inserted into the balloon catheter.
 
Event or Problem Description
It was reported that during the implant procedure, the balloon catheter was inserted into the coronary sinus and as the physician attempted to insert a guidewire into the balloon catheter, it was not possible to enter the lumen of the balloon catheter more than a few centimeters.The balloon catheter was replaced.No patient complications have been reported as a result of this event.
 
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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 Key6470395
Report Number2182208-2017-00647
Device Sequence Number16234337
Product Code DYG
UDI-Device Identifier00613994842114
UDI-Public00613994842114
Combination Product (Y/N)N
Initial Reporter CountryGM
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 Physician
Type of Report Initial
Report Date (Section B) 01/19/2017
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 Date06/28/2018
Device Model Number6215
Device Catalogue Number6215
Device Lot Number0061504143
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/19/2017
Initial Report FDA Received Date04/06/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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