As reported, during a fistulagram involving a patient of unknown age and gender, a micropuncture transitionless stiffened cannula access set wire separated.While trying to remove the inner cannula, it became stuck.When the device was removed, the wire separated.It has been reported that approximately half of the wire remains in the patient; although surgical retrieval is reportedly planned.According to the initial reporter, the patient has not experience any adverse effects due to this occurrence.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5.Investigation - evaluation.Reviews of the complaint history, device history record, drawing, manufacturer¿s instructions, and quality control procedures the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 shows no nonconforming events which could contribute to this failure mode.However, the subassembly lots did present with potentially related nonconformances.While these may relate to the reported failure, it should be noted that all effected units were scrapped and not replaced prior to order completion.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and no product returned, investigation has concluded that a root cause for this event 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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