MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ENDORETURN ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number ER23B

Device Problem Nonstandard Device (1420)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/28/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that the rotating part of the hemostasis valve on the endoreturn arterial cannula separated from the top of the device after inserting it into the right femoral artery.This cannula is intended to deliver oxygenated blood to patients requiring cardiopulmonary bypass during surgery.The hemostasis valve allows the hemostatic introduction and removal of vascular catheters such as the endoclamp aortic catheter.In this case, only minor blood loss was noted during recannulation.However, this malfunction/defect could potentially result in an exchange of the cannula with a temporary interruption of bypass and possibly significant blood loss.The potential for serious injury is not remote.The device was returned and product evaluation is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

It was reported that the rotating part of the hemostasis valve on the endoreturn arterial cannula separated from the top of the device after inserting into the right femoral artery.Minor blood loss during recannulation was noted.As reported, it was a robotic mvr procedure.The procedure was finished in normal fashion, after replacing the cannula with another cannula.The patient did fine with no issues.The event may be due to over tightening during prep or after insertion.Device malfunction was alleged.

Manufacturer Narrative

H10: additional narratives.Updated h3 and h6 per new information received.H3: product evaluation.Customer complaint of hemostasis valve separation issue was confirmed.Device was returned with visible traces of blood.As received, the hemostasis valve was fully tightened; threaded section was intact and not damaged.Indications of bonding adhesive was not visible on top thread of shaft.Per drawing dymax 191 m adhesive was applied to top threads of shaft.Valve was loosen and re-tightened without any difficulties.No visual damage, contamination, or other abnormalities were found to the device.

Manufacturer Narrative

The root cause is likely due to a defect of a supplier manufacturing.This product is supplied to edwards by a supplier manufacturer and they performed a dhr review and no relevant non-conformances were identified.

• Brand Name: EDWARDS ENDORETURN ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; one edwards way; mailstop anton 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 14187863
• MDR Text Key: 289884352
• Report Number: 2015691-2022-05336
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2022

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: 02/13/2023
• Device Model Number: ER23B
• Device Lot Number: 128256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 05/05/2022; 07/06/2022
• Supplement Dates FDA Received: 05/27/2022; 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 145 KG