It was reported that prior to use, a 3 x 18 mm xience alpine stent delivery system (sds) and a 2.5 x 8 mm nc trek balloon dilatation catheter (bdc) were found kinked along with the dispenser hoops.The bdc felt resistance removing the protective sheath and was attempted to be used.However, the balloon did not inflate despite holding pressure.The sds was not used and there was no patient involvement.A new unspecified bdc and sds were used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.No additional information was provided.
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G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual and functional inspections were performed on the returned device.The reported inflation issue was confirmed.The reported difficulty removing the protective sheath, kinked hoop and kinked protective sheath could not be tested since the hoop and protective sheath were not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported issues.It was reported by the account that even after damage was noted, the device was advanced into the patient anatomy and attempted to be used.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: prior to use examine all equipment carefully for defects.Examine the dilatation catheter for bends, kinks, or other damage.Do not use any defective equipment.In this case, it is likely that the use of the damaged device contributed to the reported complaints.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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