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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-90
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/21/2021
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 a competitor implant procedure while advancing a guidewire, the tip of the catheter dilator broke off and lodged in the right atrium.The patient underwent additional intervention to snare the tip and it was successfully removed.No 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
EI 
MDR Report Key11430143
Report Number9612164-2021-00892
Device Sequence Number4710957
Product Code DQY
UDI-Device Identifier00643169143210
UDI-Public00643169143210
Combination Product (Y/N)N
Initial Reporter StateSC
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) 03/07/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date07/22/2021
Device Model Number6248V-90
Device Catalogue Number6248V-90
Device Lot Number0009841316
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/16/2021
Initial Report FDA Received Date03/07/2021
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 Required Intervention;
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