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

Model Number	DS2C018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During an implant procedure, a pericardial effusion was observed after the cannulation of the coronary sinus with the catheter at the ostium.The effusion did not effect the condition of the patient and the implant procedure was successfully completed.Following the procedure an ultrasound imaging was performed and the effusion was stable.No further intervention is anticipated.The patient was stable and will continue to be monitored.
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
• MDR Report Key: 11936636
• Report Number: 2017865-2021-19873
• Device Sequence Number: 4102006
• Product Code: DQY
• UDI-Device Identifier: 05415067004178
• UDI-Public: 05415067004178
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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: 08/31/2023
• Device Model Number: DS2C018
• Device Catalogue Number: DS2C018
• Device Lot Number: 7680641
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention