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

Catalog Number	U6TRAP40SH
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	03/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a dxterity diagnostic catheter.The device was removed from packaging per ifu and inspected.The physician noticed ovalization of the tip prior to insertion in patient.The intended lesion was in the proximal rca, non-tortuous, severe calcification and (b)(6) stenosis.The vessel had calcified eccentric plaque.A dissection occurred during the procedure.The physician was not sure if the dxterity catheter caused the dissection, or if it was just eccentric plaque.The vessel was ivused to look at the possible dissection but the determination was unclear.The lesion was ffr at (b)(6) negative.When the possible dissection after diagnostic cath was noted on angio review, and with the uncertain ivus result, the decision was made to stent the dissection.No additional patient clinical sequelae reported.
Additional Manufacturer Narrative
Product analysis: as received the white soft tip of the catheter is oval at the entrance.Side hole located at the tip sleeve transition per specification.Review of the tip shape confirms it meets specification.Cine review: review of the image does not clarify if there is a dissection or whether this is the native appearance of the ostium where there is tight disease just distal to the guide catheter.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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: 6511096
• Report Number: 1220452-2017-00029
• Device Sequence Number: 92103
• Product Code: DQO
• UDI-Device Identifier: 20643169738571
• UDI-Public: 20643169738571
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/17/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2020
• Device Catalogue Number: U6TRAP40SH
• Device Lot Number: 60037017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided; 05/30/2017
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 06/29/2017; 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention