MAUDE Adverse Event Report: CORDIS CORPORATION CORDIS PRECISE PRO RX NITINOL STENT SYSTEM; STENT, CAROTID

Model Number PC0830RXC

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 08/18/2020

Event Type  malfunction  

Event Description

Stent would not track well, a new stent was opened.

• Brand Name: CORDIS PRECISE PRO RX NITINOL STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave; miami lakes FL 33014
• MDR Report Key: 10747162
• MDR Text Key: 213414280
• Report Number: 10747162
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/21/2020,09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PC0830RXC
• Device Catalogue Number: PC0830RXC
• Device Lot Number: 17936244
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11315 DA
• Patient Weight: 89