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As reported by the edwards (b)(6) affiliate, during preparation for a transfemoral tavr procedure, when the 14fr esheath was flushed, heparinized saline leaked from the sheath housing.It was suspected that the housing was damaged, and the sheath was replaced with new one.
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The sheath was returned unexpanded with two introducers.No applicable imagery was provided for review.Before the hemostasis valves were removed for further inspection, the esheath was flushed without any other devices or guidewire inserted.Leakage was observed from the proximal end of the sheath housing during flushing.Visual inspection of the hemostatic valves in the sheath housing revealed that a gap is present on the duckbill valve slit.No abnormalities on the cross slit valve or disc valve were noted.In addition to the amount the slit is opened, the distal segment od of the duckbill valve and housing id were taken.A bigger duckbill valve od and smaller housing id may lead to compression of the duckbill valve and introduce a gap in the duckbill slit.The measurement for housing id met specification.The measurement for the slit opening is over the specified dimension.Additionally, the measurements for the distal portion of the duckbill valve were over the specified dimension.However, this measurement may not be representative of the component as received from the supplier, as the material is subject to multiple downstream processes, which may affect the final profile of the component.Based on the measurement results, a potential defect was identified.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformance that would have contributed to this complaint event.A lot history review was performed and revealed no other similar events.A complaint history review from november 2019 through october 2020 revealed additional confirmed complaints for the esheath regarding the sheath housing, hemostasis valve leaking.The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.Of the potential root causes identified the one applicable to this complaint is a potential edwards defect: gap on slid of duck valve.The instructions for use (ifu) and device preparation manual were reviewed for instructions involving esheath use.During preparation of the device, the operator is instructed to visually inspect all components for damage.Ensure the delivery system is fully unflexed and the valve alignment wheel is adjacent to the handle.Unpack edwards esheath introducer set and visually inspect for damage.Take care not to bend, pinch, or flatten when unpacking and handling.Do not use if packaging or any components are not sterile, have been opened or are damaged (i.E.Kinked or stretched).Gently flush sheath through flushport with heparinized saline until filled and close stopcock to sheath note: keep distal tip of sheath elevated while flushing to ensure complete flushing.No ifu/training deficiencies were identified.During receiving inspection, duckbill valves are inspected on a sampling plan to ensure the break/slit on the valve meet drawing specification and that the components are free of cosmetic defects when viewed with unaided eye.The supplier also provides a certificate of conformance with each receiving lot to certify that the units meet specification.During manufacturing, the esheath is both visually inspected and tested several times throughout the process.Product verification (pv) testing was also performed on five (5) lot samples.During pv testing, the sample sheaths underwent hemostasis testing.The devices were flushed through the flush port during preparation for the hemostasis test, which would identify leaks due to abnormalities on the duckbill valve.All tested samples in the wo passed pv testing.The event was confirmed based on visual inspection and functional testing of the returned device.A review of ifu/training materials revealed no deficiencies.As reported and confirmed through functional testing, a leak was observed coming from the proximal end of housing when the sheath was flushed with no device or guidewire inserted through the sheath.Per training materials, sheath hemostasis (while no device is inserted) is maintained by the duckbill valve located in the sheath housing.Visual inspection of the returned device noted a gap on the slit of the duckbill valve.The observed gap is responsible for fluid leakage from the housing when flushing the device.At this time, it is unable to be determined if the faulty component is related to the supplier, or edwards manufacturing.The following potential scenarios may have occurred: ¿ a gap/break on the slit was present as received from the supplier.This gap/break was missed prior to component assembly in the sheath housing (100% inspection) and assembled into the sheath housing.¿ a gap/break on the slit was not present as received from the supplier.During housing assembly and downstream procedures, the component could have been inadvertently damaged.¿ a gap/break on the slit was not present as received from the supplier.After housing assembly, interaction (compression) between the housing and the valve, due to od profile of the valve, could have introduced a gap/break on the component.Note: it cannot be definitively determined if measured od is representative of part as received from supplier, or a result of material interaction with ew processes (silicone application, sterilization).Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.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.As there is a potential for a supplier and/or edwards manufacturing issue, an assessment was conducted to determine if a scar or capa is required.The issue was escalated to supplier quality for further investigation.Based on severity of the issue as identified no scar is required.Capa assessment was performed.There is a potential edwards defect.The defect is not a labeling defect.The specific complaint event did not result in an outcome with a severity/criticality of 3 or higher.The specific complaint event did not exceed the existing complaint trending control limits.An assessment of complaints resulting in similar hazardous situation/harm as this complaint event indicates that the rate of occurrence exceeds predicted thresholds.As the specific complaint event exceeds existing occurrence rate a capa is required.However, based on the following rationale, no capa will be opened at this time.No patient impact ¿ no harm was reported to the patient.While complaints exceed predicted occurrence rates, the overall risk level remains the same (low).Complaint trending indicates complaint is within established control limits, continue to monitor and escalate as required per established trending and complaint evaluation procedure.As a precautionary measure, an awareness communication was performed, focusing on the manufacturing processes involving valve inspection and esheath assembly.As a potential non-conformance was identified a product risk assessment (pra) is required.However, based on a meeting with management regarding the issue, it was concluded that no pra is required.Justification for no pra generation and detailed information were documented.
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