H10: manufacturing review: a manufacturing related cause was considered.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 delivery system was returned for evaluation and the slide block, a force transmitting component was no longer connected to the proximal sheath.The disconnection of the slide block is considered to led to the reported impossibility to deploy the stent.In addition a thread inside the delivery system was found broke off from the slide block; however, this is considered to be not the initial cause for the reported issues, but a cascading effect due to the initial disconnection.Based on evaluation of the sample the inability of an adhesive joint (slide block/tether/diving sheath) to withstand tension force during deployment is confirmed.A definite root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the instructions for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to failure to deploy and high deployment forces.With regards to preparation and accessories, the instructions for use states "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated".Holding and handling of the system throughout deployment was found sufficiently described.H10: d4 (expiry date: 11/2023), g3, h6 (device).H11: h6 (method, result).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.H3 other text : see h10.
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