MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS LIFESCIENCES ESHEATH+ 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	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs) during a transcatheter aortic valve replacement (tavr) with a 26mm sapien 3 ultra resilia valve during valve inflation the 26mm commander delivery system (ds) balloon ruptured the burst appeared to be radial.There was difficulty bringing the ds back into the sheath and a snare was used to bring the ds back into the sheath.The ds and sheath were then being brought out as one unit, but the nose cone appeared to be stuck at the access site.A wire cutter was used to snip the ds that was outside the patient and vascular surgery was called to help with removal and possible cutdown.A non-edwards sheath was placed over the portion of the balloon that was still in the patient's groin.Then the rest of the balloon came out of the groin.The groin was then closed using a non-edwards device.The valve was successfully implanted, and the patient is in stable condition.The ratio of contrast to saline was 15ml of contrast to 15:85.There was no sheath damage and valve alignment was done in a straight section.Engineer evaluation found the distal tip was split.

• Brand Name: EDWARDS LIFESCIENCES ESHEATH+ 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: 24743047
• Report Number: 2015691-2026-13700
• Device Sequence Number: 9165991
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)271007(11)251007
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/05/2026

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: 67047357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2025
• 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: Male
• Patient Weight: 112 KG