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

Model Number	410212
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2022-17306.It was reported that the patient presented to a scheduled procedure.During the implant procedure, the catheter could not be advanced smoothly through the left ventricular lead.The physician suspected that the catheter was bent.While attempting to implant the left ventricular lead, the lead exhibited high threshold and failure to capture.The left ventricular lead implant was abandoned as the patient developed coronary sinus dissection during the procedure.The patient condition was stable post-procedure.
Additional Manufacturer Narrative
The reported event of insertion difficulty was not confirmed.As received, a partially split catheter without its hemostasis valve was returned for analysis.Due to the missing hemostasis valve and damaged catheter, an insertion test could not be performed.All damages found were consistent with procedural damage.

• Brand Name: CPS DIRECT PL
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15201092
• Report Number: 2017865-2022-17308
• Device Sequence Number: 15013166
• Product Code: DQY
• UDI-Device Identifier: 05414734207072
• UDI-Public: 05414734207072
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: 09/30/2024
• Device Model Number: 410212
• Device Catalogue Number: 410212
• Device Lot Number: 8202802
• 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: 08/02/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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: Other
• Patient Sex: Unknown