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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 6248DEL90DL02
Medical Device Problem Code Detachment Of Device Component (1104)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 09/27/2017
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 delivery and inner straight catheter were positioned in order to select a vein for the left ventricular (lv) lead.When the physician removed the inner catheter, the radiopaque tip got lost and lodged into coronary sinus.The tip at the time remained in the left lung.The patient is being observed and will follow up.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
MDR Report Key7090336
Report Number9612164-2017-01724
Device Sequence Number1933197
Product Code DQY
UDI-Device Identifier00613994746832
UDI-Public00613994746832
Combination Product (Y/N)N
Initial Reporter CountryAR
PMA/510(K) Number
K053431
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/06/2017
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? Yes
Operator of Device Health Professional
Device Expiration Date01/10/2019
Device Model Number6248DEL90DL02
Device Catalogue Number6248DEL90DL02
Device Lot Number0008439588
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/03/2017
Initial Report FDA Received Date12/07/2017
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 Age65 YR
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