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

Model Number	DS2C029
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was difficult to slit during the implant procedure.As a result, the physician slightly cut himself on the hand.The physician was in stable condition.
Additional Manufacturer Narrative
As received, a complete cps tool was returned in one piece for analysis.A visual inspection of the cps tool revealed it was cracked and damaged which is consistent with an improper slitting technique used in the field.

• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20355672
• Report Number: 2017865-2024-65598
• Device Sequence Number: 20625924
• Product Code: DQY
• UDI-Device Identifier: 05415067004284
• UDI-Public: (01)05415067004284(10)10106184(17)261130
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 03/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DS2C029
• Device Lot Number: 10106184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 03/07/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 01/14/2025; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2023
• 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
• Patient Sex: Unknown