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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-90L
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/02/2017
Type of Reportable Event Malfunction
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 catheter came apart during slitting.The catheter snapped apart about five inches distal to the valve when the slitter reached that point.The physician grasped the torn edge of the catheter with forceps and continued slitting to successfully remove the catheter.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
MDR Report Key7094350
Report Number9612164-2017-01805
Device Sequence Number19141200
Product Code DQY
UDI-Device Identifier00643169143180
UDI-Public00643169143180
Combination Product (Y/N)N
Initial Reporter StateCT
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) 12/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/27/2019
Device Model Number6248V-90L
Device Catalogue Number6248V-90L
Device Lot Number0008733150
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/02/2017
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
Patient Age69 YR
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