MAUDE Adverse Event Report: COVIDIEN VIANCE CROSSING CATHETER; CATHETER, PERCUTANEOUS

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

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of medtronic¿s chronic total occlusion (cto) devices: the viance crossing catheter, the enteer re-entry catheter and the enteer guidewire.Survey results are received for an interventional cardiologist with 15 years¿ experience who has been using the viance crossing catheter, the enteer re-entry catheter and the enteer guidewire devices since 2019.The respondent used 30 enteer guidewire devices, 20 viance crossing catheter devices overall, and 30 enteer re-entry catheter devices overall, all within the past 12 months.During use of viance crossing catheter, the respondent reports device related complications of artery spasm (2 events) which were described as constriction of the artery downstream from the catheter, and embolism (3 events) described as distal embolization of plaque fragments with mild ischaemia.Both of these events were reported to be somewhat concerning.

• Brand Name: VIANCE CROSSING CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 9966971
• MDR Text Key: 191850745
• Report Number: 2183870-2020-00112
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K113589
• 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: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2020
• 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