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As reported, during an interventional radiology procedure using a three-way plastic stopcock, the tap melted when handling chemotherapy and lipiodol.There was leakage of the chemoembolization product through the tap.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Description of event: as reported, during an interventional radiology procedure using a three-way plastic stopcock, the tap melted when handling chemotherapy and lipiodol.There was leakage of the chemoembolization product through the tap.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, manufacturing instructions, and quality control data.The complainant returned the complaint devices and 7 unused sealed devices to cook for investigation.Physical examination of the returned device showed: four used stopcocks were received.Inspection found three have visible cracks.No crack was noticed on the fourth.It was leak tested and no leak had occurred.Additionally, seven sealed devices were received, and all stopcocks were inspected with four found to have visible cracks.No cracks were noted for the remaining three stopcocks.The stopcocks with no cracks were leak tested, and no leakage was detected.The cracked unused stopcocks will be addressed in (b)(4).At this time, cook concluded that the devices were manufactured within specification.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows three other complaints associated with the complaint device lot.Although multiple complaints have been reported for this lot, a capa investigation was previously completed and found that the root cause of cracking/leaking stopcocks was determined to be stopcock stems molded of nylon 6 have the potential to absorb moisture resulting in an increase in diameter raising the potential for cracking of the stopcock body.Due to this environmental effect, cook could not conclude that nonconforming product from this lot exists in house or in the field.The reported product does not come provided with an instructions for use (ifu) pamphlet.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded the device design contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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