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It was reported that during an unknown procedure, four three-way plastic stopcocks leaked during the procedure.It was reported that the physician was using the device off label with onyx for an embolization when the leaks were observed.These four were reported to be disposed of.The physician then tested three other devices and observed cracks in them, and glue leaking from the sides.An additional three unopened devices are expected to be returned to the manufacturer with the three that were tested.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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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Information was received from the company representative indicating the procedure being performed was an embolization with glue procedure and the customer was "well aware" of it's off label use but has done it several times before.The procedure was completed successfully using other methods.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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B5: information was received from the company representative indicating the procedure being performed was an embolization with glue procedure and the customer was "well aware" of it's off label use but has done it several times before.The procedure was completed successfully using other methods.Investigation evaluation.A review of the complaint history, device history record, quality control, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that three used, and three unused (inside sealed packages) plastic 3-way stopcocks were returned for investigation.All devices were functionally tested and examined for cracks.All three devices exhibited leaks and presented with cracks.Further clarification provided that the three used devices were in fact prior to use and tested without making patient contact.All six of these devices have been confirmed in (b)(4).While the four used devices will be confirmed with cracks and leakage within (b)(4).Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The device history record was reviewed and found to be complete.One nonconformance was noted on the work order and expanded on through the database.This nonconformance noted that there were no extra devices for the water test.The rework personnel signed the signature line and included ¿replaced¿ on the same line.The plastics supervisor was consulted on the meaning and process behind correcting this nonconformance.She stated that once quality control caught this particular nonconformance, the lot would be sent back to production where the missing devices would be added, as indicated on the work order by ¿replaced,¿ and sent back to quality control.Based on this confirmation from the supervisor and the revisions to the work order formatting, no further actions or escalation measures will be taken at this time.It should also be noted other complaints for this lot number include the related complaint (b)(4).And an additional complaint from 2015, (b)(4).With the same failure mode.Furthermore, a review of the quality control procedures was conducted, and a gap was discovered.The quality control procedures note that the products tested on high pressure must be discarded.However, the work order does not notate or list that those devices from the lot were in fact checked or discarded.The current practice within production does not support how the manufacturing procedures.Measures are being conducted to address this gap.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted to address this failure mode.Per the quality engineering risk assessment no further action is required.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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