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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-MP
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Vascular Dissection (3160)
Date of Event 10/01/2021
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, a coronary sinus dissection occurred during the use of the catheter.It was noted that the patient had a stenosed coronary sinus.The catheter was removed and the implant procedure was completed successfully.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
EI 
MDR Report Key12623601
Report Number9612164-2021-03926
Device Sequence Number1239913
Product Code DQY
UDI-Device Identifier00763000160326
UDI-Public00763000160326
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K123153
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/13/2021
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 Date01/04/2023
Device Model Number6250V-MP
Device Catalogue Number6250V-MP
Device Lot Number0010750582
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/01/2021
Initial Report FDA Received Date10/13/2021
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 Age37 YR
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