MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PROPLEGE; CORONARY SINUS CATHETER

Model Number PR9

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

Vascular perforations may occur with the use of several of our devices.A perforation is typically the result of excessive force combined with challenging anatomy and not a malfunction of the device.In this case, it was reported that there was a hole noted in the rv that required repair.Follow-up is in progress for additional information and the availability of the device for return.The root cause of the event remains indeterminable at this time.If new information is received, a supplemental report will be submitted.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that during placement of the cs catheter upon initial contrast injection it was noted that there was an effusion, the catheter was locked in place and it was discussed to watch the patient and possibly wait and do the case the next day.The surgeon decided he wanted the catheter removed to see how stable the patient was and at that point the patient started to crash and had to perform immediate sternotomy.There was 400cc of blood in the effusion.There was a hole noted in the rv and the hole was repaired and the procedure was performed without further complications and patient was stable.

Manufacturer Narrative

Additional manufacturer narrative: edwards received additional information through follow-up.The surgeon stated that the injury to the patient was not created from the catheter.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.

• Brand Name: PROPLEGE
• Type of Device: CORONARY SINUS CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 12050 lone peak parkway; m/s mle 2; draper, UT 84020 ; 9492502289
• MDR Report Key: 6778970
• MDR Text Key: 82329238
• Report Number: 3008500478-2017-00040
• 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,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2017
• Device Model Number: PR9
• Device Catalogue Number: PR9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2017
• 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
• Patient Age: 79 YR