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

Catalog Number	U5TRAP40SH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intimal Dissection (1333); Patient Problem/Medical Problem (2688)
Date of Event	08/04/2017
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 was using a dxterity diagnostic catheter when treating the proximal lad, moderate tortuosity, non-calcified, no stenosis.No damage was noted to the device packaging.No issues noted when removing the device from the packaging.The device was inspected and prepped per ifu with no issues.No resistance was encountered when advancing the device, excessive force was not applied.A dissection occurred near the location of the tip of the catheter and was treated with a resolute onyx stent.It is reported that the physician does not think that the catheter caused the dissection, based on the patient's clinical symptoms, this dissection may have already been there.No other device was in this vessel.No additional patient clinical sequelae reported.
Additional Manufacturer Narrative
Cine image review: the dissection can hardly be identified at the origin of lcx.The potential cause of the dissection might be the catheter tip although a pre-existing dissection cannot be ruled out.The dissection is located at the lcx.A pre-existing dissection cannot be ruled out since the initial projection for the left coronaries does not show a perpendicular view of the lcx.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: 6851125
• Report Number: 1220452-2017-00092
• Device Sequence Number: 1228713
• Product Code: DQO
• UDI-Device Identifier: 20643169738564
• UDI-Public: 20643169738564
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/23/2018

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: 01/12/2020
• Device Catalogue Number: U5TRAP40SH
• Device Lot Number: 60038768
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 02/23/2018
• 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
• Patient Age: 65 YR