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

Model Number	6248V-90L
Medical Device Problem Codes	Detachment Of Device Component (1104); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the delivery catheter was returned and analyzed.The mechanical operation of the catheter was damaged.Visual analysis of the catheter indicated damage during use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the tip of the catheter fell off while wiping the catheter.The catheter was not used in a patient.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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: 7254597
• Report Number: 9612164-2018-00249
• Device Sequence Number: 16363093
• Product Code: DQY
• UDI-Device Identifier: 00643169143180
• UDI-Public: 00643169143180
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K123153
• 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,Followup
• Report Date (Section B): 04/10/2018

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: 08/03/2017
• Device Model Number: 6248V-90L
• Device Catalogue Number: 6248V-90L
• Device Lot Number: 0007663611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1