H10: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the sample was returned for evaluation.The returned catheter sample was found with locked safety and loaded stent; the system was found bloody indicating insertion into patient but an indication for a failure to cross could not be found.The tip was found in good condition, and damage was not visible which leads to inconclusive evaluation result for failure to cross the lesion.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: 'if resistance is met during delivery system introduction, the system should be removed and another system should be used.' the instructions for use further state: 'gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath (¿) insert a 0.035 inch (0.89 mm) diameter guidewire of appropriate', and 'predilation of the lesion should be performed using standard techniques.' h10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent xl vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent xl vascular stent products are identified in d2 and g4.H10: d4(expiry date: 08/2023).H11: g1, h6(result and conclusion).H11: section a through f - the information provided by bd represents all of 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.
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