MAUDE Adverse Event Report: MEDTRONIC, INC DXTERITY TRA; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	U5TRAN35SHA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A dxterity diagnostic catheter was used during a normal heart cath procedure.No damage was noted to the packaging.The device was removed from packaging per ifu and inspected with no issues noted.The device was prepped per ifu with no issues noted.No alleged product malfunction is reported.The vessel associated with the event had mild calcification and mild tortuousity.After the procedure the patient became lethargic.Mri showed showed stroke from right carotid side which is the side that the catheter was introduced.Patient fully recovered.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: DXTERITY TRA
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7540197
• Report Number: 1220452-2018-00066
• Device Sequence Number: 13901785
• Product Code: DQO
• UDI-Device Identifier: 20643169738779
• UDI-Public: 20643169738779
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K161287
• 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): 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2020
• Device Catalogue Number: U5TRAN35SHA
• Device Lot Number: 60072304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1