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

Model Number	6227DEF04
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
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 broke apart when slitting.Subsequently, another catheter was used, and the same issue happened.It was noted that the blade from the slitter was defective.The catheter was replaced, and another slitter was used, which worked correct, but the physician decided to use a scalpel and kelly clip to cut the catheter.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: 8321878
• Report Number: 9612164-2019-00463
• Device Sequence Number: 1691342
• Product Code: DQY
• UDI-Device Identifier: 00613994450753
• UDI-Public: 00613994450753
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K061480
• Number of Events Summarized: 1
• 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): 02/08/2019

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: 06/13/2020
• Device Model Number: 6227DEF04
• Device Catalogue Number: 6227DEF04
• Device Lot Number: 0009182563
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR