MAUDE Adverse Event Report: ABBOTT CPS DIRECT PL; CATHETER, PERCUTANEOUS

Model Number	410213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During an implant procedure, a pericardial effusion was observed via diagnostic imaging.The physician alleged a perforation was the cause of the effusion, however, it remains unknown on whether or not the catheter was related to the event.No allegation of malfunction was made against the catheter.Pericardiocentesis was performed to resolve the effusion and the procedure was completed as expected.The patient was in stable condition following the procedure.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: CPS DIRECT PL
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12746351
• Report Number: 2017865-2021-35092
• Device Sequence Number: 4985603
• Product Code: DQY
• UDI-Device Identifier: 05414734207089
• UDI-Public: 05414734207089
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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: 01/31/2024
• Device Model Number: 410213
• Device Catalogue Number: 410213
• Device Lot Number: 7840336
• Was Device Available for Evaluation?: No
• 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: 10/19/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EPIMYOCARDIAL LV LEAD; EPIMYOCARDIAL LV LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown