MAUDE Adverse Event Report: ABBOTT CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER; CATHETER, PERCUTANEOUS

Model Number DS2C020

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

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

Event Date 11/26/2019

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

During implant of the left ventricular (lv) lead, there was difficulty inserting the delivery cathether into the coronary sinus.It was noted that the catheter had caused a dissection leading to a pericardial effusion.The lv lead was not implanted; the patient was stable following the procedure and will continue to be monitored.

• Brand Name: CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT; 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9531741
• MDR Text Key: 178605654
• Report Number: 2182269-2019-00254
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 05415067004192
• UDI-Public: 05415067004192
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: DS2C020
• Device Lot Number: 7127419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention