Catalog Number ENC453700 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: (b)(6).Section h.3: 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.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8470638.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Event Description
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The healthcare professional reported that during an endovascular embolization procedure, the 4.5mm x 37mm no tip enterprise¿ 2 vascular reconstruction device (enc453700 / 8470638) ¿was found to be released in the microcatheter hub.¿ the stent body was separated prematurely from the delivery wire.The physician retracted the stent and switched to a new stent to complete the procedure using the original microcatheter.There was no report of any negative patient impact.On 13-dec-2023, additional information was received.The information indicated that the introducer was verified to be fully seated and secured in the microcatheter hub.The enterprise device did move out forward out of the introducer during insertion through the y connector / hub.Nothing unusual was noted about the system prior to use.The concomitant microcatheter used was a prowler select plus (catalog / lot# unknown).Adequate continuous flush was maintained through the microcatheter.Aside from the premature detachment, the stent / stent delivery system did not appear damaged when it was removed.The replacement stent was another 4.5mm x 37mm no tip enterprise¿ 2 vascular reconstruction device (enc453700).There was no clinically significant delay in the procedure due to the reported issue.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 09-jan-2024.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4.5mm x 37mm no tip enterprise¿ 2 vascular reconstruction device was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the stent was already detached from the unit.The delivery wire and the introducer were in good condition (i.E., no kinks, bends, or elongations).Microscopic inspection was performed on the stent component.It was observed to be in good condition; there was no structural damage (i.E., no broken struts, no kinks); also, it was noted fully expanded, both ends can be noted as completely flared.The retraction bump and marker distance were subjected to dimensional analysis, and all measurements were found to be within specification.Since the distance between the delivery wire tip and reference marker was found to be within specifications, manufacturing or design defects are not suspected.The reported issue documented in the complaint regarding a stent being released in the microcatheter hub was confirmed since the stent was noted as already separated from the delivery system.However, the dimensional analysis performed showed no issues that could have resulted in the premature detachment of the stent.With the information available, the root cause of the failure encountered cannot be determined.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.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8470638.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does 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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Search Alerts/Recalls
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