MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN SELECT II; CATHETER, PERCUTANEOUS

Model Number	6248V-90
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
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 an implant procedure the proximal end of the sheath separated from the distal end while slitting the delivery catheter.The delivery catheter was replaced and a new delivery catheter was used to complete the implant procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the delivery catheter was returned and analyzed.The mechanical operation of the catheter slitting showed a spiral slit.The mechanical operation of the catheter was damaged (broken into two pieces).The mechanical operation of the catheter shaft was kinked.Visual analysis of the catheter indicated damage during use.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN SELECT II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8426546
• Report Number: 9612164-2019-00919
• Device Sequence Number: 16593082
• Product Code: DQY
• UDI-Device Identifier: 00643169143210
• UDI-Public: 00643169143210
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K123153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: 11/27/2020
• Device Model Number: 6248V-90
• Device Catalogue Number: 6248V-90
• Device Lot Number: 0009462886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 03/16/2019
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 94