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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN COMMAND; CATHETER, PERCUTANEOUS
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MEDTRONIC IRELAND ATTAIN COMMAND; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 6250C02
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cardiac Tamponade (2226)
Date of Event 03/05/2018
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 an implant procedure as the coronary sinus was being entered by the catheter and contrast given, the patient experienced a mild pericardial tamponade.The procedure was aborted and the patient was reported to be recovered the following day.No further patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN COMMAND
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key7459994
Report Number9612164-2018-00882
Device Sequence Number16395521
Product Code DQY
UDI-Device Identifier00613994334831
UDI-Public00613994334831
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K080428
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) 04/25/2018
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 Date09/19/2018
Device Model Number6250C02
Device Catalogue Number6250C02
Device Lot Number0008544098
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/05/2018
Initial Report FDA Received Date04/25/2018
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 Other;
Patient Age71 YR
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