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

Model Number	ER21B
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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.
Event or Problem Description
Edwards received a report of an er21b issue during an rmvr procedure where the icf100 could not pass through.There was no abnormality detected prior to use or after the event.The er21b was inserted into the femoral artery without problem and arterial line test was done successfully.Icf was correctly prepped preop but would not pass through the end of the er21b end.It was not the rhv per clinical feedback; the wire was able to go through but not the icf100.The icf was de-aired again with negative suction and retried.The er21b was adjusted a bit more laterally and secured.Again, the icf was attempted multiple times but unable to pass through the end of the er21b.The er21b was removed successfully and new er21b was inserted (from the same lot).The same icf was inserted into the er21b and successfully passed through the end of the er21b.Procedure was done successfully.Patient status reported as fine, but there was minor blood loss during cannula exchange.Neither the device nor the icf100 that was used is available for return.
Additional Manufacturer Narrative
H11 corrected data- investigation type corrected from "device not returned" to "device discarded" for clarification.H11 manufacturer narrative: additional information/ updates: g3 awareness date, g6 follow up type and number, h2 selections, b4 date of report.H6 type of investigation codes, investigation findings, and investigation conclusions updated.Narrative: the complaint is unable to be confirmed.Ifu/ labelling adequate.No corrective action required.No images were provided and the subject device was not returned for evaluation.Per dhr review, no rework, deviation, or nc was associated with this work order.There are various manufacturing mitigations in place including inspecting for damaged and/or kinked cannula.There are inspections in place by the supplier to ensure damaged devices get identified and rejected during the manufacturing process.As the subject device was not returned, evaluation could not be performed and a definitive root cause of the alleged issue is unable to be conclusively determined at the time; however, operational factors, including handling during device preparation and/or insertion may have contributed to the issue.There is no evidence of an edwards/ supplier manufacturing defect.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.

• Brand Name: ENDORETURN ARTERIAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: dannette crooms ; 1 edwards way; irvine, CA 92614 ; 8015656209
• MDR Report Key: 21638161
• Report Number: 2015691-2025-02036
• Device Sequence Number: 12879915
• Product Code: DWF
• UDI-Device Identifier: 00690103191400
• UDI-Public: (01)00690103191400(17)260407(10)BSLC8543
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K971291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2026
• Device Model Number: ER21B
• Device Lot Number: BSLC8543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/19/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown