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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND SELECTSITE; CATHETER, PERCUTANEOUS
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MEDTRONIC IRELAND SELECTSITE; CATHETER, PERCUTANEOUS Back to Search Results
Model Number C304XL7405
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event 03/14/2019
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 the catheter used during an attempted coronary sinus cannulation, had caused cardiac perforation and effusion.The catheter was removed and discarded.No further patient complications have been reported as a result of this event.
 
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Brand Name
SELECTSITE
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key8483728
Report Number9612164-2019-01180
Device Sequence Number13943665
Product Code DQY
UDI-Device Identifier00613994729798
UDI-Public00613994729798
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K061416
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) 04/04/2019
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 Date07/22/2020
Device Model NumberC304XL7405
Device Catalogue NumberC304XL7405
Device Lot Number0009248000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/14/2019
Initial Report FDA Received Date04/04/2019
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 Age71 YR
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