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

Model Number ER21B

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 08/18/2022

Event Type  Injury  

Event Description

It was reported that after cannulating the femoral artery with the er21b a test dose was performed.High line pressures of the arterial cannula was observed.An echo exam was performed showing a dissection of the descending aorta.They stopped the cannulation process and decannulated once it was determined it was safe to do so.The surgeon complained that the transition from the obturator to cannula is not smooth causing a concern for dissection.The patient did not have any further complication related to the arterial dissection.As reported, the team performed a cutdown on the right common femoral artery, placed pursestring, needle, wire visualized on tee free on descending thoracic aorta and then seldinger technique.There was minimal vessel tortuosity.The incident occurred pre-bypass.The rep thinks probably the wire and dilators from the biomedicus venous cannula were used.Only tee was used during advancement and positioning.The dissection occurred on iliac artery.No repair was required.No blood loss was noted.The patient has no history of pvd.The transition from the obturator to cannula was easy, however, the dissection was a surprise.

Manufacturer Narrative

Typically when using the endoreturn catheter, the obturator is passed through the cannula with minimum resistance.In this case the transition from the obturator to cannula was not smooth.The patient developed a descending aortic dissection during endoreturn cannulation.The device was not returned for evaluation, as it is unavailable.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Manufacturer Narrative

Based on the information available, the complaint is unable to be confirmed and a definitive root cause cannot be conclusively determined; however, patient and/or procedural factors may have contributed.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.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.

• Brand Name: 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: 15402092
• MDR Text Key: 299687010
• Report Number: 2015691-2022-07824
• 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
• Report Date: 10/20/2022

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 Model Number: ER21B
• Device Catalogue Number: ER21B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Life Threatening