It was reported, during an embolization procedure, the tuohy-borst large bore clear plastic sidearm adapter leaked when connected to another manufacturer's catheter.Reportedly, the complaint device would not tighten down on the microcatheter.The back-end leaked.This occurred during prepping and during the procedure.However, the procedure was successfully completed with the device.The patient did not experience any adverse effects as a result of this procedure.No additional interventions were required.This event occurred in three distinct procedures which are reported under medwatch report references: 1820334-2019-00746 and 1820334-2019-00748.Each of these three events occurred on either (b)(6) 2019.The complaint device for this event was discarded at the facility.Reportedly, four unused devices are available to aid in the manufacturer's investigation.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.A review of the functional test, inspection of unused product, complaint history, device history record, manufacturing instructions, drawing, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the four returned, unused devices did not reveal any damage.The seals of the devices were examined, and none of the devices leaked during testing.There is no evidence to suggest that the devices were not manufactured to specification.Additionally, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were two other reported complaints for this lot number, both reported at the same time and from the same customer as this complaint.Furthermore, a review of the manufacturer¿s instructions, drawing, and quality control procedures was conducted, and no gaps were discovered.Moreover, the product labeling provided with the device was also reviewed, but it does not address this specific failure mode.Based on the information provided, the examination of the returned product, and the results of our investigation, the cause of this event can be traced to the user and unintended use error.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.
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