MAUDE Adverse Event Report: ABBOTT CPS QUARTET INNER-SUB-ACU 135MEAN 59CM; CATHETER, PERCUTANEOUS

Model Number	DS2N026-59
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During an initial implant procedure, which advancing the catheter, the patient sustained a tear in the coronary sinus vein.Contract was injected and the catheter was visualized out of the vein on fluoroscopy.An echocardiogram was performed and did not reveal any additional symptoms.The surgery was ended without implanting system.The patient was stable and no addition intervention was required to address the dissection.

• Brand Name: CPS QUARTET INNER-SUB-ACU 135MEAN 59CM
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20903091
• Report Number: 2017865-2024-72183
• Device Sequence Number: 9052879
• Product Code: DQY
• UDI-Device Identifier: 05415067005717
• UDI-Public: (01)05415067005717(10)9063550(17)260430
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130252
• 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): 02/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: DS2N026-59
• Device Lot Number: 9063550
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• 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