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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 6250V-EH
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Vascular Dissection (3160)
Date of Event 03/06/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a coronary sinus or venous dissection occurred while advancing the delivery catheter and the patient's blood pressure had dropped.No effusion was noted.The patient received fluids and blood pressure and pulse then stabilized.The lead implant was abandoned.The patient is a participant in the world-wide randomized antibiotic envelope infection prevention trial clinical study.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 Key6924985
Report Number9612164-2017-01411
Device Sequence Number787811
Product Code DQY
UDI-Device Identifier00643169142886
UDI-Public00643169142886
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K123153
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/21/2017
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 Date07/11/2018
Device Model Number6250V-EH
Device Catalogue Number6250V-EH
Device Lot Number0008439592
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/21/2017
Initial Report FDA Received Date10/06/2017
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 Hospitalization; Life Threatening;
Patient Age78 YR
Patient Weight107
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