As reported, during angiography and possible stenting of the tibial arteries, foreign matter was found upon flushing a cxi support catheter.The device was opened and flushed and then threaded over another manufacturer's 0.014 inch, 300 centimeter, hydrophilic-coated, stainless steel wire guide with a nitinol tip; however, the catheter would not track over the wire.The catheter was removed from the wire and flushed again, at which time "some green colored matter" came out of the catheter.Per the reporter, there was no apparent damage to the wire guide.The complaint device was discarded and another device of the same type was used to complete the procedure, using the original wire guide.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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Initial report: as reported, during angiography and possible stenting of the tibial arteries, foreign matter was found upon flushing a cxi support catheter.The device was opened and flushed and then threaded over another manufacturer's 0.014 inch, 300 centimeter, hydrophilic-coated, stainless steel wire guide with a nitinol tip; however, the catheter would not track over the wire.The catheter was removed from the wire and flushed again, at which time "some green colored matter" came out of the catheter.Per the reporter, there was no apparent damage to the wire guide.The complaint device was discarded and another device of the same type was used to complete the procedure, using the original wire guide.Investigation - evaluation.Reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirms that one prior to use cxi support catheter was returned for investigation.The device was not damaged.The device was flushed with water, and no green matter was noted exiting the catheter.No issues were identified with the device during the analysis.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Given this information, there is no evidence to suggest that non-conforming product from this lot exists in house or in the field.An ifu is provided with this device, which states ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided and the examination of the returned product, investigation has concluded that a cause for the failure could not be determined at this time.It is possible that the reported green matter may have been the coating on the other manufacturer¿s wire guide.The complaint rate aligns with current risk documentation, and no further escalation is required at this time.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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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