MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CPS DIRECT SL II (SLITTABLE) OUTER GUIDE CATHETER

Model Number DS2C003

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Pericardial Effusion (3271)

Event Date 10/23/2018

Event Type  Death  

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 Description

Related manufacturer report number: 2017865-2018-16470. During an implant procedure, there were insertion difficulties noted while inserting the left ventricular (lv) lead into a lateral vein and there were high pacing thresholds and phrenic nerve stimulation. The lead was being repositioned when the patient became hypotensive. An echocardiogram was performed, revealing a pericardial effusion which was treated with a pericardiocentesis. The lv lead was removed, the implant procedure was abandoned, and a cardiothoracic surgeon performed a thoracotomy to resolve the effusion. It was suspected that the decrease in blood pressure was due to the anticoagulant therapy of the patient. The patient was transferred to the intensive care unit and is currently stable. There were no performance issues noted with any abbott devices during the procedure.

Event Description

Additional information was received indicating that the cardiac perforation was due to a non-abbott device.

Event Description

Additional information was received indicating that the patient expired. The primary cause of death was septic shock and there was no allegation that any abbott device caused or contributed to the patient's death.

• Brand Name: CPS DIRECT SL II (SLITTABLE) OUTER GUIDE CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8048151
• MDR Text Key: 126452689
• Report Number: 2017865-2018-16677
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (Y/N): N
• Reporter Country Code: IT
• PMA/PMN Number: K092075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/07/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: DS2C003
• Device LOT Number: 6457402
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 05/16/2018
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 11/07/2018 Patient Sequence Number: 1

Treatment

1456Q/86, (B)(4)