MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CPS DIRECT¿; CATHETER, PERCUTANEOUS

Model Number	410213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2023-94634.Related manufacturer reference number: 2017865-2023-94635.Related manufacturer reference number: 2017865-2023-94636.It was reported during a system implant procedure, the patient experienced a cardiac perforation resulting in pericardial effusion.The entire system was removed to resolve the issue.No further adverse patient consequences were reported.
Additional Manufacturer Narrative
The reported event indicated surgery was suspended due to pericardial effusion.As received, only the dilator was returned for analysis the catheter used at the procedure was not returned.Visual examination found the dilator was normal no anomalies were noted.
Additional Manufacturer Narrative
This correction report is being submitted to update d1 and d4 to align with the global unique device identification database (gudid).

• Brand Name: CPS DIRECT¿
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18315542
• Report Number: 2017865-2023-94638
• Device Sequence Number: 14990626
• Product Code: DQY
• UDI-Device Identifier: 05414734207089
• UDI-Public: (01)05414734207089(10)8416425(17)250331
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 410213
• Device Catalogue Number: 410213
• Device Lot Number: 8416425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 01/24/2024; 06/12/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/02/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown