MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number	6227DEF04
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2018
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 a problem occurred during slitting of the catheter.During slitting of the deflectable catheter, the slitting blade encountered a wire.The physician stopped during slitting, made an adjustment and completed the slit without complications.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8142355
• Report Number: 9612164-2018-03513
• Device Sequence Number: 1910809
• Product Code: DQY
• UDI-Device Identifier: 00613994450753
• UDI-Public: 00613994450753
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K061480
• Number of Events Summarized: 1
• 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): 12/07/2018

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 Date: 04/25/2020
• Device Model Number: 6227DEF04
• Device Catalogue Number: 6227DEF04
• Device Lot Number: 0009110442
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR