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As reported, during a cerebral embolization and using a tuohy-borst large bore clear plastic sidearm adapter, it was noted to be leaking blood out of the back.Three of these devices were being used at the same time and all had the same problem.The access site was the right groin, and the target site for the procedure was the cerebral vasculature.They were able to successfully complete the procedure with other side arm adapters from another manufacturer.The rep tested an unused device from this lot number and also witnessed leaking.No section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a cerebral embolization and using a tuohy-borst large bore clear plastic sidearm adapter, it was noted to be leaking blood out of the back.Three of these devices were being used at the same time and all had the same problem.The access site was the right groin, and the target site for the procedure was the cerebral vasculature.They were able to successfully complete the procedure with other side arm adapters from another manufacturer.The rep tested an unused device from this lot number and also witnessed leaking.No section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Investigation evaluation: reviews of the complaint history, device history record, manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection and functional test of the returned devices as also conducted.Eighty-eight tuohy-borst large bore clear plastic sidearm adapters were received in a unused condition and one device was received in prior to use condition.A leak test was performed on all the unused sidearms with none found to be leaking.Leak testing of the one prior to use device as it came out of the bag resulted in leaking.However, once the adapter valve was tightened down, as would be performed by a physician once the adapter was over a device, the device no longer leaked.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.Cook concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.From the information provided upon review of the customer testimony, dmr, dhr, and inspection of returned devices, cook concluded that the devices were manufactured to specification.The returned devices did not leak in the lab, however, the three complaint devices were not among those returned.Therefore, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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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