MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS LIFESCIENCES RETROGRADE CARDIOPLEGIA CATHETER

Model Number RC014T

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

Additional narratives: it was reported that there was difficulty in removing the insertion stylet from a cannula during use.The stylet was eventually removed, and the cannula continued to be used with no patient injury.Difficulty removing the handle stylet from the cannula may result in the inability to use the device.This may require an exchange for an unaffected device and may result in a minor delay in the procedure.In this case, it was alleged that the patients coronary sinus could have been damaged while removing the stylet.The device was returned and product evaluation is ongoing.If new information becomes available, a supplemental report will be submitted.

Event Description

Edwards received information that the stylet of a retrograde cardioplegia cannula was too hard and it was difficult to remove from the cannula during use.It was unknown if there was resistance when the stylet was removed from the cannula at the inflation test before use; however, the surgeon felt an intense resistance at the female luer connector and near the handle of the stylet during use.Although there was no patient injury, the patients coronary sinus was about to get damaged when removing the stylet.The cannula was not exchanged and was used for the surgery.There were no patient complications reported.The patient status was reported as under treatment.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections h6 (type of investigation, investigation findings, investigation conclusions).There's no evidence to suggest an edwards manufacturing defect.Dhr review was performed and no related nonconformances were found.There is a manufacturing inspection in place to ensure that 'stylet shouldn't drag or catch during insertion' which the unit/lot passed.Based on the available information, the complaint is unable to be confirmed and a definitive root cause cannot be conclusively determined.A manufacturing defect is not confirmed.As there was no issue detected with the reported device, patient/procedural factors may have contributed to the event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

H3: evaluation summary: customer report of stylet removal difficulty from the cannula was unable to be confirmed.Device was returned with visible traces of blood.As received, stylet was detached from the cardioplegia cannula and was able to be inserted without difficulty.Female luer connector remained intact and observed to have no damage at the threads.Stylet was able to be removed without difficulty and passed through returned cannula with no resistance.The female luer lock dimensionally passed iso standard.No other visual damage, contamination, or other abnormalities were found to the device.The reported event was not confirmed through preliminary evaluation of the device.The device has been sent for further testing and analysis.A supplemental report will be submitted accordingly once the evaluation has been completed.

• Brand Name: EDWARDS LIFESCIENCES RETROGRADE CARDIOPLEGIA CATHETER
• Type of Device: CARDIOPLEGIA CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: gail warner ; one edwards way; mailstop 6.1 anton; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12492639
• MDR Text Key: 272738318
• Report Number: 2015691-2021-05248
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2023
• Device Model Number: RC014T
• Device Lot Number: 63310885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/10/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 57 KG