Manufacturing review: a complaint history review was performed.This is the first complaint reported for this lot number.A device history record review was performed and the lot met all release criteria.Investigation summary: the device was returned for evaluation.The result of the investigation is confirmed for the reported flushing issue.The inner lumen of the device was attempted to be flushed however this was unsuccessful.The definitive root cause for the reported difficult to flush issue could not be determined based upon the available information.Labeling review: the instructions for use for the bantam pta balloon catheter was reviewed and contains the following information relevant to the reported event: directions for use: inspection and preparation remove the protective sheath by first withdrawing the stylet and then slowly removing the sheath while holding the catheter as close to the balloon as possible.If any resistance is felt, or if any stretching of the catheter is observed while removing the protective sheath, the product should not be used.The catheter should then be inspected for bends, kinks or stretched portions.Do not use if product damage is evident.Prepare a mixture of contrast medium and normal saline as per normal procedure.(recommended 25% /75%) attach a stopcock and a 20 ml syringe half filled with the contrast solution to the balloon port.Point the syringe nozzle downward and aspirate until all air is removed from the balloon.Turn the stopcock off and maintain the vacuum in the balloon.Purge the catheter guidewire lumen thoroughly.Reinserting the balloon into the protective sheath may damage the balloon or catheter.(expiry date: 04/2024).
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