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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN SELECT II; CATHETER, PERCUTANEOUS
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MEDTRONIC IRELAND ATTAIN SELECT II; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 6248V-130
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Vascular Dissection (3160); Pericardial Effusion (3271)
Date of Event 09/17/2020
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 coronary sinus was dissected when the catheter was being used.It was noted that the catheter had "jumped" forward and effusion was observed.A pericardiocentesis was performed, blood was taken out of the pericardial space, and the procedure was aborted.No further patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN SELECT II
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
IE 
MDR Report Key10626989
Report Number9612164-2020-03768
Device Sequence Number11420733
Product Code DQY
UDI-Device Identifier00643169143203
UDI-Public00643169143203
Combination Product (Y/N)N
Initial Reporter StateCA
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) 10/05/2020
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? Yes
Operator of Device Health Professional
Device Expiration Date08/10/2022
Device Model Number6248V-130
Device Catalogue Number6248V-130
Device Lot Number0010334708
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/17/2020
Initial Report FDA Received Date10/05/2020
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 Required Intervention;
Patient Age81 YR
Patient Weight82
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