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

Catalog Number U5TRAP40SH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Patient Problem/Medical Problem (2688)

Event Date 08/04/2017

Event Type  Injury  

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 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.

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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6851125
• MDR Text Key: 85272802
• Report Number: 1220452-2017-00092
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20643169738564
• UDI-Public: 20643169738564
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2020
• Device Catalogue Number: U5TRAP40SH
• Device Lot Number: 60038768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2018
• Date Device Manufactured: 01/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR