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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Vascular Dissection (3160)
Date of Event 02/20/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during the implant procedure, the balloon catheter caused a coronary sinus dissection.It was noted that flow was maintained, and the procedure continued as planned.No further 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 Key8434012
Report Number2182208-2019-00538
Device Sequence Number1019825
Product Code DYG
UDI-Device Identifier00613994842114
UDI-Public00613994842114
Combination Product (Y/N)N
Initial Reporter CountryUK
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) 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date03/06/2019
Device Model Number6215
Device Catalogue Number6215
Device Lot Number0061548832
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/20/2019
Initial Report FDA Received Date03/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening;
Patient Age80 YR
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