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); Myocardial Infarction (1969); Vascular Dissection (3160)

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 from an interventional cardiologist in practice 15 years.In the past 12 months the physician performed 200 procedures using the dxterity diagnostic catheter.100 procedures using the 5 fr x 100cm, 50 procedures using the intermediate sizes, and 50 procedures using the 6f x 125cm.The following complications adverse events/effects were encountered when using the dxterity diagnostic catheter over the last 12 months: one dissection event occurred which was related to the procedure but not directly to the medtronic dxterity diagnostic catheter.Two myocardial infarction events occurred which were related to the procedure but not directly to the medtronic dxterity diagnostic catheter.5 vasospasm events occurred which were related to the procedure but not directly to the medtronic dxterity diagnostic catheter.(no vascular occlusion was reported) it was reported that deformation occurred during use in one case.The event was related to the procedure but not directly to a medtronic dxterity diagnostic catheter.

Manufacturer Narrative

The deformation during use event had impact on the procedure, but no clinical/patient impact.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: 9749337
• MDR Text Key: 183680602
• Report Number: 1220452-2020-00026
• 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,Followup
• Report Date: 03/25/2020

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: 03/05/2020
• 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