MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CPS DIRECT PL (PEELABLE) OUTER GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	410173
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during procedure that the catheter tip had broken off from the sheath.The tip became wedged in the patient's pulmonary artery.Retrieval was attempted but unsuccessful.The pocket was closed.The patient was stable.
Additional Manufacturer Narrative
The reported event of ¿tip of the cps delivery system had broken off of the sheath¿ was confirmed.As received, a cps catheter was returned with dilator and insertion tool for analysis.Visual inspection of the catheter found the distal tip to be damaged, and the grey soft tip was detached and not returned for analysis.
Additional Manufacturer Narrative
Correction: previously reported as 'prolonged surgery' malfunction, corrected h6 and b5 to reflect intubation and event type updated to serious injury,.
Event or Problem Description
During retrieval attempt, patient intubation was necessary.Following procedure, the patent was taken to the intensive care unit.

• Brand Name: CPS DIRECT PL (PEELABLE) OUTER GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17030966
• Report Number: 2017865-2023-22031
• Device Sequence Number: 6459263
• Product Code: DQY
• UDI-Device Identifier: 05414734206815
• UDI-Public: 05414734206815
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2024

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: 03/31/2025
• Device Model Number: 410173
• Device Catalogue Number: 410173
• Device Lot Number: 8448793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 09/15/2023; 06/13/2024
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 09/15/2023; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White