MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER

Model Number	DS2C021
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Vascular Dissection (3160)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Related manufacturer reference number: 2938836-2019-04385.Related manufacturer reference number: 2938836-2019-04386.It was reported that during an initial implant procedure, after implantation of a right ventricular pacing lead, the physician attempted to implant a quadripolar passive lead in the left ventricle.Physician complained of tightness of sub-selector around the lv lead.The lead couldn¿t be advanced all the way through the sub selector of the inner catheter.Another inner catheter was used to complete the procedure.However, the distal coronary sinus (cs) was perforated/ dissected while using the cps universal delivery system outer and inner catheters.The perforation resulted in significantly lowered blood pressure, cardiac tamponade, and loss of pulse readings.The patient lost a significant amount of blood.The patient was administered chest compressions, received multiple external defibrillator shocks for spontaneous vf, and was administered an intrathoracic needle and chest tube to evacuate blood from the pericardium.The implant of the left ventricular lead was discontinued after the tamponade occurred.Upon hemodynamic normalization of the patient, a right atrial lead and a dual chamber pacemaker were implanted to complete the implant procedure.At the end of the procedure, the patient was minimally responsive, and the decision was made to attempt targeted body temperature management for more than 24 hours.The patient¿s current condition is stable.

• Brand Name: CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8667955
• Report Number: 2938836-2019-04387
• Device Sequence Number: 19397394
• Product Code: DQY
• UDI-Device Identifier: 05415067004208
• UDI-Public: 05415067004208
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K130257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: DS2C021
• Device Lot Number: 6117707
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CPS QUARTET INNER; QUARTET
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR