MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 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 Code	Perforation of Vessels (2135)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2022-11824.Related manufacturer reference number: 2017865-2022-11827.It was reported that a patient presented in-clinic for an explant procedure.Examination of the patient's lead revealed high capture thresholds.During the procedure and during an attempt to place a left ventricular lead was found to be difficult to remove from the guidewire, and the left ventricular lead was found to be damaged.Additionally, a steerable catheter used was found to have perforated the patient blood vessels, resulting in additional surgical intervention to resolve the complication.The exiting lead was capped on (b)(6) 2022, and implant of the left ventricular lead was abandoned.The patient was stable throughout.
Additional Manufacturer Narrative
The reported event of ¿due to repeated operation, the coronal sinus orifice was interbedded¿.As received only the dilator was returned for analysis.The catheter was not returned.Visual examination did not find any anomalies.

• Brand Name: CPS DIRECT UNIVERSAL SLITTABLE OUTER 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14605058
• Report Number: 2017865-2022-11825
• Device Sequence Number: 5065057
• Product Code: DQY
• UDI-Device Identifier: 05415067004185
• UDI-Public: 05415067004185
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2022

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: 08/31/2023
• Device Model Number: DS2C019
• Device Catalogue Number: DS2C019
• Device Lot Number: 7673495
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 09/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2020
• 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