MAUDE Adverse Event Report: ABBOTT CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER; CATHETER, PERCUTANEOUS

Model Number	DS2C019
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	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, pericardial effusion was observed suspected to be due to cardiac perforation as a result of incorrect intubation of the coronary sinus (cs) ostium with the catheter.Following the procedure, the pericardial effusion was treated with pericardial drainage and an additional surgery.No additional intervention has been performed at this time.The current status of the patient is unknown.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.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 UNIVERSAL SLITTABLE OUTER CATHETER
• 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: 14569580
• Report Number: 2017865-2022-11473
• Device Sequence Number: 12295056
• Product Code: DQY
• UDI-Device Identifier: 05415067004185
• UDI-Public: 05415067004185
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: DS2C019
• Device Catalogue Number: DS2C019
• Device Lot Number: 8255992
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown