Device is a combination product.(b)(4).Device evaluated by mfr.: the stent delivery system (sds) was returned for analysis without the distal part of the device including parts of the midshaft, outer, inner , balloon, stent and tip.A visual and tactile examination of the midshaft section found the midshaft broken at 164mm distal from the hypotube to the midshaft bond.The damage most likely occurred due to excessive tensile force being applied to the delivery system.A review of the outer extrusion, inner lumen and bi-component bond could not be completed as the distal part of the device was not returned for examination.Additional information on how the distal part detached and if it was still available for analysis had been requested from the customer however no response was received.A visual and tactile examination found the corewire kinked and no other issues with the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.Distal part of the delivery catheter was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
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Reportable based on device analysis completed on 14-dec-2016.It was reported that difficulty prepping device was encountered.During preparation of a 2.50 x 20 synergy ii drug-eluting stent, the stylet got stuck in the stent and could not be removed.The procedure was completed with another 2.50 x 20 synergy ii drug-eluting stent.No patient complications were reported.However, returned device analysis revealed shaft break.
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