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Catalog Number 606S255X |
Device Problems
Failure to Advance (2524); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2023 |
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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00803.
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Event Description
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As reported by the field, during a stent assist coil embolization to the anterior communicating artery, a neuromax sheath was placed in target site and the prowler select plus 150/5cm microcatheter (606s255x, 31045127) was delivered into the guide catheter.When the microcatheter (mc) was delivered to about c6-c7 segment, the microcatheter was impeded in the guide catheter and could not advance any more.The physician pushed the unspecified stent into the microcatheter, the stent was found to be impeded proximal of the microcatheter (the stent did not enter the vessel) and could not advance any more.The doctor removed the microcatheter and stent from patient and switched to a new microcatheter to complete the surgery.The stent was not replaced.The procedure was prolonged about 10 minutes, not clinically significant.Additional information received on 01-nov-2023 indicated that the stent was an enterprise2 intracranial stent (product and lot number unknown).The mc did not mc kinked or bent.
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Manufacturer Narrative
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Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a stent assist coil embolization to the anterior communicating artery, a neuromax sheath was placed in target site and the prowler select plus 150/5cm microcatheter ((b)(4)) was delivered into the guide catheter.When the microcatheter (mc) was delivered to about c6-c7 segment, the microcatheter was impeded in the guide catheter and could not advance any more.The physician pushed the unspecified stent into the microcatheter, the stent was found to be impeded proximal of the microcatheter (the stent did not enter the vessel) and could not advance any more.The doctor removed the microcatheter and stent from patient and switched to a new microcatheter to complete the surgery.The stent was not replaced.The procedure was prolonged about 10 minutes, not clinically significant.Additional information received on 01-nov-2023 indicated that the stent was an enterprise2 intracranial stent (product and lot number unknown).The mc did not mc kinked or bent.A non-sterile 150cm x 5cm prowler select plus microcatheter was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no appearance of damages were observed.A microscopic inspection was performed along the body of the prowler, and no damages were found.(i.E., no elongations, kinks, or compressed conditions).The device was flushed with a laboratory sample syringe.After that, a 0.018-inch guide wire was inserted into the received microcatheter.The guidewire could be advanced until it came out from the distal tip of the microcatheter without noticeable resistance.Then, a lab sample envoy 6f was flushed, and the microcatheter was inserted.The device was able to pass through the entire length, and no abnormalities were felt.The inner diameter (id) and outer diameter (od) were measured, and they were found to be within specifications.The issue reported that the microcatheter was impeded in the guide catheter was not able to be confirmed since during the functional test, the device performed without difficulties.The issue reported that the stent was found to be impeded in the proximal end of the microcatheter was neither confirmed, the guidewire being able to pass through the entire length of the microcatheter indicated that it was not obstructed.No damages were found on the microcatheter that could have contributed to the issues encountered during the procedure.Other circumstances or problems may have occurred during the use of the device that could not be replicated during the analysis.Therefore, the customer complaints were not confirmed.As part of cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.Since no issues with the device were identified, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contain the following caution: ¿if strong resistance is met during manipulation, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the catheter and guidewire as a system.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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Manufacturer Narrative
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Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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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