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

Model Number	PC0940RXC
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Stent would not open, sheath not retracted due to device failure.

• Brand Name: CORDIS PRECISE PRO RX NITINOL STENT SYSTEM
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave; miami lakes FL 33014
• MDR Report Key: 13365992
• Report Number: 13365992
• Device Sequence Number: 17474777
• Product Code: NIM
• UDI-Device Identifier: 20705032036525
• UDI-Public: (01)20705032036525(17)221130(10)17991340
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/21/2022
• Report Date (Section F): 01/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: PC0940RXC
• Device Catalogue Number: PC0940RXC
• Device Lot Number: 17991340
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 01/21/2022