Catalog Number ENCR402312 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6).Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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As reported by the field, the physician opened the packaging of an enterprise2 intracranila stent 4mmx23mm (encr402312, 8269504) and removed the device from dispenser hoop, it was found that the stent was released automatically.The stent body was separated prematurely from the delivery wire.The device was not used in patient.The physician switched to a new stent to complete the surgery.There was no patient injury reported as the device was not clinically used.
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Manufacturer Narrative
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Product complaint (b)(4).Complaint conclusion: as reported by the field, the physician opened the packaging of an enterprise2 intracranila stent 4mmx23mm (encr402312, 8269504) and removed the device from dispenser hoop, it was found that the stent was released automatically.The stent body was separated prematurely from the delivery wire.The device was not used in patient.The physician switched to a new stent to complete the surgery.There was no patient injury reported as the device was not clinically used.No additional information is available.A non-sterile 4mm x 23mm enterprise 2 vascular reconstruction device was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and it was noted that the stent was already detached from the unit and this was not returned for evaluation.The delivery wire and the introducer were in good condition (i.E., no kinks, bents, or elongations).The delivery wire was subjected to dimensional analysis and all measurements were found to be within specification, including those specifications that control the attachment and delivery of the stent.Therefore, device failure is not suspected to be a contributing factor.The customer complaint regarding a premature deployment of the stent during the removal from the hoop was confirmed due to the detached condition of the stent; however, with the amount of information available and the lack of returned components, no further investigation can be conducted.It is possible that clinical and procedural factors, including device manipulation, may have contributed to the reported failure.There is no indication that the issues reported in the complaint result from a defect inherently related to the enterprise device.(b)(6) medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 8269504.The history records indicate this product was final inspection tested at (b)(6) medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: if resistance is met during manipulation, determine the cause of resistance before proceeding.Do not apply undue force if resistance is encountered at any point during stent manipulation.Withdraw the unit and advance a new one.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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Search Alerts/Recalls
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