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

Catalog Number UNK-CV-DAN-DXT

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

Patient Problems Muscle Spasm(s) (1966); Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A post market clinical follow-up (pmcf) survey was conducted on behalf of medtronic to seek out potential new risks and assess performance of the dxterity diagnostic catheter.Survey results were obtained from an interventional cardiologist in practice 18 years.In the past 12 months the physician performed 180 procedures using the dxterity diagnostic catheter.25 procedures using the 5 fr x100cm, 130 procedures using the intermediate sizes, and 25 procedures using the 6f x 125cm.The following complications adverse events/effects were encountered when using the dxterity diagnostic catheter product over the last 12 months.1 plaque dislodgement event occurred which was related to the procedure but not directly to the medtronic dxterity diagnostic catheter 3 vasospasm events occurred which were related to the procedure but not directly to the medtronic dxterity diagnostic catheter.In one case the dxterity diagnostic catheter did not perform as expected when delivering guidewires to selected sites in the coronary and vascular system.This was attributed to a very kinked subclavian artery.

• 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 ; IE ; 091708734
• MDR Report Key: 9749291
• MDR Text Key: 184118634
• Report Number: 1220452-2020-00025
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-DAN-DXT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2020
• 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): Other