MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) 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	Vascular Dissection (3160)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an initial implant procedure, after implanting the leads, the catheter was used for a coronary sinus cannulation.Contrast was then injected and it was observed that there was a dissection of the coronary sinus.The physician decided to not implant the left ventricular (lv) lead.The patient is stable with no consequences.

• Brand Name: CPS DIRECT PL
• 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: 50304253
• Report Number: 2017865-2026-17238
• Device Sequence Number: 21508056
• Product Code: DQY
• UDI-Device Identifier: 05414734207089
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 08/20/2026

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: 410213
• Device Lot Number: 11045143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2025
• 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