MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PROPLEGE CORONARY SINUS CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number PR9

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

Patient Problem Arrhythmia (1721)

Event Date 06/11/2014

Event Type  Injury  

Event Description

It was reported that upon placement of the proplege coronary sinus catheter in the coronary sinus the patient coded, coronary sinus catheter was removed and cpr was administered.Patient was stabilized and case was canceled.It was found out later that the patient had bradycardic episode in preop holding.

Manufacturer Narrative

The device was not retained by the hospital for evaluation.At this time, there is no allegation of product malfunction but only an adverse event associated with the use of an edwards device.The device was discarded at the hospital.Per the complaint description, this complaint is not device related but a use or patient related issue.The root cause of the cardiac arrhythmia cannot be determined.Arrythmia is listed as a potential complication in the ifu.No corrective actions are being taken at this time.Manufacturing records were reviewed and there were no nonconformances associated with this lot.Trends will continue to be monitored by the edwards quality systems.

• Brand Name: PROPLEGE CORONARY SINUS CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: walt wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 3913716
• MDR Text Key: 4494045
• Report Number: 3008500478-2014-00095
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2014

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 Expiration Date: 12/01/2014
• Device Model Number: PR9
• Device Lot Number: 59703321
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/11/2014
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2014
• Initial Date Manufacturer Received: 06/11/2014
• Initial Date FDA Received: 07/03/2014
• Date Device Manufactured: 02/10/2014
• 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 Age: 86 YR
• Patient Weight: 67