MAUDE Adverse Event Report: EDWARDS LIFESCIENCES RETROGRADE CARDIOPLEGIA CATHETER

Model Number RC014T

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

These cannulae are used to divert large volumes of blood between the patient circulation and the cardiopulmonary bypass machine during cardiac surgery and, on occasion, ecmo (off-label use).This malfunction/defect would likely require an exchange of the cannula resulting in a temporary interruption of bypass and possibly significant blood loss.The potential for serious injury before or during use is not remote.The device is in the process of being returned.If new information becomes available, a supplemental report will be submitted.

Event Description

It was reported that the handle of this cannula broke while inserting cannula into heart.As reported, the issue led to an increased risk as main body of catheter remained in patient and introducer could not be removed easily.

Manufacturer Narrative

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.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.

Manufacturer Narrative

H10: additional narratives.Updated h3 and h6 per new information received.H3: product evaluation.Customer report of broken stylet handle was confirmed.Device was returned with visible traces of blood.As received, the distal end of the stylet handle was broken off and was returned with device.Cross surfaces of broken stylet appeared uneven and rough.The two broken sections appeared to match up.The returned introducer stylet was able to be removed from the cannula with no difficulty.No other visual damage, contamination, or other abnormalities were found.

• Brand Name: RETROGRADE CARDIOPLEGIA CATHETER
• Type of Device: CARDIOPLEGIA CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 11584326
• MDR Text Key: 242810058
• Report Number: 2015691-2021-02133
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2023
• Device Model Number: RC014T
• Device Lot Number: 63122029
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention