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

Model Number	914ESA
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported, during research and development (r&d) testing, the 14fr esheath distal tip tore when when the valve was exiting the sheath.No damage to the valve was observed.No patient involvement.
Additional Manufacturer Narrative
The 14fr esheath was returned for evaluation and a torn distal tip was confirmed by imagery.The device was accidentally misplaced therefore functional and dimensional testing were unable to be performed.Imagery found that the distal tip was torn radially and hdpe stretched along the axial opening/tear.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the complaint code.The following instructions for use (ifu) were reviewed: esheath, commander delivery system, device preparation training manual, and the procedural training manual.Based on this review, no ifu/training deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaint of a torn distal tip was confirmed through the imagery provided.However, no manufacturing nonconformance was identified during the evaluation.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were noted during device unpacking or preparation.As reported, "during r&d testing, esheath tip tear occurred when the valve was exiting the sheath." per evaluation of the provided imagery, the sheath distal tip was observed to be torn radially.This failure mode is characteristic of sheath tip tear events as described in a previous risk assessment.While a conclusive root cause was unable to be determined, previous investigation indicates that the tear is attributed to improper tip expansion, resulting in interference between the valve and sheath tip.As such, it is possible that improper tip expansion contributed to the experienced distal tip tear.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: EDWARDS 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: 18350544
• Report Number: 2015691-2023-18500
• Device Sequence Number: 20168941
• Product Code: DYB
• UDI-Device Identifier: 00690103193985
• UDI-Public: (01)00690103193985(17)241003(10)65304055
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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: 10/03/2024
• Device Model Number: 914ESA
• Device Lot Number: 65304055
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2022
• 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