MAUDE Adverse Event Report: CORDIS CORPORATION ADROIT; CATHETER, PERCUTANEOUS

Model Number	67203400
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Cordis 6fr al 0.75 guide catheter used in catheterization procedure was noted by doctor to be kinked while in patient.Doctor was able to remove by snaring device out.

• Brand Name: ADROIT
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 5452 betsy ross drive; santa clara CA 95054
• MDR Report Key: 16245700
• Report Number: 16245700
• Device Sequence Number: 12375322
• Product Code: DQY
• UDI-Device Identifier: 20705032065266
• UDI-Public: (01)20705032065266
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 01/04/2023
• Report Date (Section F): 01/04/2023

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: 67203400
• Device Catalogue Number: 67203400
• Device Lot Number: 18159951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2023
• 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: Male
• Patient Weight: 79 KG
• Date Report Sent to FDA: 01/04/2023