MAUDE Adverse Event Report: MEDTRONIC, INC DXTERITY

Model Number U5ULTRA40SH

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

Patient Problem Injury (2348)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was stated that a dxterity diagnostic catheter was attempted to be used.It was reported that a damping effect was observed after the contrast injection despite been in the aorta.

• Brand Name: DXTERITY
• 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 ; IE ; 091708734
• MDR Report Key: 10281732
• MDR Text Key: 199067845
• Report Number: 1220452-2020-00058
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00763000016753
• UDI-Public: 00763000016753
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K161287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2022
• Device Model Number: U5ULTRA40SH
• Device Lot Number: 60175311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/16/2020
• Date Device Manufactured: 03/15/2019
• 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