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

Model Number	916ESPA
Medical Device Problem Codes	Material Separation (1562); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of two manufacturer reports being submitted for this case.Investigation is underway.
Event or Problem Description
As reported by an edwards lifescieces field clinical specialist, regarding a 29mm sapien 3 valve in the aortic position.As the 29mm sapien 3 valve and 29mm commander delivery system was exiting the 16f esheath plus there was additional resistance.The valve and delivery system were getting stuck at the tip of the sheath but was able to be advanced.The sheath appeared visibly normal on fluoro.Procedure was continued.During deployment the 29mm commander delivery system balloon appeared to inflate more on proximal end than distal end which appeared unusual.Valve placement was as intended and no issues with valve upon implant.Once sheath was removed the distal end of the sheath appeared to be missing.Tip not found.No injury at this time.Patient is stable and was discharged.
Additional Manufacturer Narrative
A supplemental mdr is being submitted to reference a related reports.Sections: g3, g6, h2, h10 have been updated.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to the return of the device.Sections: d9, g3, g6, h2, h3, h6 device code, type of investigation have been updated.Investigation is underway.

• 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: 24688009
• Report Number: 2015691-2026-13501
• Device Sequence Number: 15866474
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)260815(11)240815
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup,Followup
• Report Date (Section B): 06/02/2026

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 Expiration Date: 08/15/2026
• Device Model Number: 916ESPA
• Device Lot Number: 65944355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 04/07/2026; 05/29/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/08/2026; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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