H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the e-luminexx vascular stent that are cleared in the us.The pro code and 510 k number for the e-luminexx vascular stent are identified in d2 and g4.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the stent delivery system was returned for evaluation without stent and with activated deployment system.The t-luer was found detached from the slide but no other damage or deficiency could be found on the returned system; the mechanism was found fully functioning.It was not known when and how the stent was deployed.Therefore, the investigation confirms detachment of the t-luer from the slide.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.The instructions for use state: 'should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit.' regarding device warning, the instructions for use state, 'visually inspect the bard e-luminexx vascular stent to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment'.Regarding accessories, the instructions for use state ´the bard s.A.F.E.6f delivery system requires a minimum 8f guiding catheter or a minimum 6f introducer sheath' also 'via the femoral route, insert a 0.035¿ (0.89 mm) guide wire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion'.The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.H10: d4 (expiry date: 03/2024), g3 h11: d4(medical device lot number), h6 (method, result, conclusion) h11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.
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