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

Model Number	914ESPA
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field clinical specialist (fcs), the patient went into complete heart block after the aortic valve was crossed with a wire requiring a tvp placement.During valve deployment, balloon rupture was noted.Physician was able to get the ruptured balloon back into the sheath and take everything out as a unit.During assessment it was noted that the nose cone along with the part of the ruptured balloon were left in the body.Both the nose cone and part of the ruptured balloon were then retrieved using a snare.Due to vascular injury and uncontrolled bleeding, cutdown was performed for repair and hemostasis was achieved.Patient departed the hybrid lab in stable condition.Upon follow up, the fcs advised that during the procedure, a balloon-related complication was observed involving the delivery system.The event initially presented as a radial balloon burst (p1) and subsequently progressed to a balloon tear (p2) as the delivery system was withdrawn from the body in conjunction with the sheath.At the time of the initial burst, the balloon and nose cone remained intact as a single unit; however, during device removal, the assembly separated into two pieces.The nose cone and a portion of the balloon material remained within the body and were successfully retrieved using a snare.The balloon had been prepared at nominal volume with no additional volume added, and no leakage was noted in the delivery system during device preparation.Blood was observed in the inflation device (atrion) following the balloon rupture.Valve alignment was not reported to be difficult and was performed in a straight section of the anatomy.No balloon aortic valvuloplasty (bav) was performed prior to implantation, and no damage to edwards devices was noted prior to the procedure.Due to the balloon tearing into two pieces, the exact location of the rupture could not be identified.The physicians were unable to determine a definitive root cause for the event.A 3mensio report and procedural images were noted as available for review.The device was discarded following the procedure.An imaging review was performed on the photos that were received of the devices.The distal part of the esheath shaft appeared to be punctured.
Additional Manufacturer Narrative
This is 2 of 2 reports.Investigation is ongoing.

• Brand Name: EDWARDS ESHEATH PLUS INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 25143362
• Report Number: 2015691-2026-15085
• Device Sequence Number: 13147352
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)280112(11)260112
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/02/2026

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 Model Number: 914ESPA
• Device Lot Number: 67389811
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2026
• 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