The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this event could be, "improper material selection (stiffness, material impact resistance, aging stability)".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "if resistance is felt when removing either the catheter or the guidewire from the working sheath, stop and consider removing them as a single unit to prevent damage to the product.Applying excessive force to the catheter can result in tip breakage or balloon separation." "only a physician who has an understanding of the clinical applications, technical principles and associated risks associated with balloon dilation of the nephrostomy tract should use this device." "the x-force® nephrostomy balloon dilation catheter is a sterile, single use device.Carefully inspect the catheter and the sterile packaging for signs of damage that may have occurred during shipment.Do not use the product if damage is evident." "store in a cool, dry and dark place.Do not store near radiation or ultraviolet light sources as these may damage product materials." the device was not returned.
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