MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) CPS Direct Universal Slittable Outer Catheter; Catheter, Percutaneous

Model Number	DS2C020
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	09/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an implant procedure, a cardiac perforation occurred and was confirmed via contrast in the pericardial space.Additionally, diagnostic imaging was performed and confirmed a pericardial effusion.The implant procedure was abandoned, but the patient was in stable condition leaving the operating room.

• Brand Name: CPS Direct Universal Slittable Outer Catheter
• Common Device Name: Catheter, Percutaneous
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50838718
• Report Number: 2017865-2026-19813
• Device Sequence Number: 9949675
• Product Code: DQY
• UDI-Device Identifier: 05415067004192
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: DS2C020
• Device Lot Number: 11299501
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/21/2026
• 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: Other
• Patient Sex: Unknown