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

Model Number DS2C019

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 12/05/2020

Event Type  Injury  

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 reference number: 2017865-2020-25196.It was reported that the patient presented for an upgrade to biventricular implantable cardioverter defibrillator.During the procedure, the left ventricle lead could not be implanted as the delivery of the lead to the target vessel was unsuccessful.The lead was removed and the venogram balloon was placed to redefine the target vessel.Upon injection of contrast it was noted that the coronary sinus was dissected and a small amount of contrast infiltrated the pericardium.The delivery system was removed and the lead was successfully replaced.A cardiac echocardiogram was done post procedure which demonstrated a very mild pericardial effusion.It was decided not to intervene on the effusion.Patient was stable.

• Brand Name: CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
• Type of Device: 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: 11094502
• MDR Text Key: 224275539
• Report Number: 2017865-2020-25197
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2020

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
• Device Operator: Health Professional
• Device Model Number: DS2C019
• Device Catalogue Number: DS2C019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2020
• Initial Date FDA Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: QUARTET LEAD SMALL-S, 86 CM
• Patient Outcome(s): Other
• Patient Age: 75 YR