As reported by the field, on the catheter table, the package of an enterprise2 4mmx23mm no tip intracranial stent ((b)(6)) was opened, and the device pulled from the hoop according to the instructions for use (ifu).When attempted to insert the enterprise 2 into the prowler select plus microcatheter (mc), found that delivery wire was protruded from distal part of introducer and the stent fell off onto the catheter table.The enterprise 2 was not clinically used.Since the same size was not available, replaced with a 4.0 x 16 mm enterprise 2, which was implanted to the lesion and the procedure was successfully completed.The physician¿s comment included that as always, both the introducer and delivery wire were held when pulling the enterprise 2 out of the hoop.Suspected that the stent part had been already slightly protruding from the introducer.A continuous flush was done.
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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: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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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