MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH PLUS INTRODUCER SET; INTRODUCER, CATHETER

Model Number	914ESPA
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned for evaluation.Investigation is underway.
Event or Problem Description
As reported by an edwards lifesciences field clinical specialist, regarding implantation of a 26mm sapien 3 ultra resilia valve in the aortic position.Access was obtained from the left side.The 14f esheath plus went in without issues.The 26mm commander delivery system went in without issues.The 26mm sapien 3 ultra resilia valve was deployed without issues.During removal of the 14 f esheath plus, the sheath had split completely through and the introducer was sticking out through the split.The patients peripherals were fine after the procedure and no harm done to the patient.Imagery was provided for review and the picture provided showed a liner tear.The device was returned for evaluation and the pre decontamination observations showed a distal tip split on the sheath.

• Brand Name: EDWARDS ESHEATH PLUS INTRODUCER SET
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 25151083
• Report Number: 2015691-2026-15115
• Device Sequence Number: 9397174
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)271203(11)251203
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K200258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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 Model Number: 914ESPA
• Device Lot Number: 67226551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2025
• 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