MAUDE Adverse Event Report: CENTERPOINT SYSTEMS CPS LOCATOR 3D DELIVERY CATHETER; PERCUTANIOUS CATHETER

Model Number	DS2C200-42
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Very little information was provided regarding this event, even after repeated follow-ups.Centerpoint could not determine any device malfunctions and could not determine the health impact to the patient.Based on the event description, centerpoint is reporting this incident out of caution to ensure compliance to the applicable regulatory requirements.The distributor has indicated that there is no additional information available.
Event or Problem Description
Cps locator sheath perforation through the right ventricle apex.
Additional Manufacturer Narrative
This report is a follow-up to the report 3015970743-2025-00003.Centerpoint received additional information about the event.The patient had to undergo additional intervention during the initial procedure to correct the perforation through the heart.The patient was hospitalized following the procedure.On (b)(6) 2025, centerpoint was informed that the patient made a full recovery.
Event or Problem Description
Additional information was received regarding the event reported in 3015970743-2025-00003.The patient required intervention during the same procedure to repair the perforation.The patient remained in the hospital following the procedure for a prolonged period to monitor the condition.The patient fully recovered.

• Brand Name: CPS LOCATOR 3D DELIVERY CATHETER
• Common Device Name: PERCUTANIOUS CATHETER
• Manufacturer (Section D): CENTERPOINT SYSTEMS; 3338 parkway blvd; west valley city UT 84119
• Manufacturer Contact: teresa clark ; 3338 parkway blvd; west valley city, UT 84119 ; 8017082817
• MDR Report Key: 21462149
• Report Number: 3015970743-2025-00003
• Device Sequence Number: 15373628
• Product Code: DQY
• UDI-Device Identifier: 00810024670123
• UDI-Public: 00810024670123
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K230363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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 Model Number: DS2C200-42
• Device Lot Number: CL13392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown