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The international customer reported that, during the use of the neff percutaneous access set, the tip of the wire guide could not be retracted through the needle.It was reportedly stuck and detached from the rest of the guide, and became lodged in the patient's right renal parenchyma.As a consequence, the tip of the wire guide remained in the patient and was not retrieved.The customer confirmed that no additional procedures were performed to attempt to recover the fragment of the wire.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
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Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control data, specifications, and visual inspection/ dimensional verification of the device was conducted during the investigation.Clinical assessment: the customer states, ¿the tip of the guide could no longer retract from the needle.¿ it is feasible to suggest the attempt to retract the wire through the needle contributed to the wire guide separation.Therefore, the probable cause of this event is user technique related.Two needle cannulas, a stiffening cannula, a trocar, and a wire guide were returned in a used condition.1 needle cannula and the stiffening cannula both contained a trocar in the lumen.The distal portion of the wire guide was unraveled with both the proximal and distal welds of the guide being found intact.The mandril diameter and the inner diameter of the needle cannula were both measured within specifications.It is likely that the wire guide became unraveled during removal from the needle cannula.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.Additionally, a search of the manufacturer's complaint database revealed no additional complaints have been reported for lot 8133562.Based on this information, the root cause of this complaint is likely use technique.It was stated that the customer could not retract the guide through the needle, which goes against the warning affixed to the wire guide holder stating that damage may occur if the wire guide is withdrawn through a needle.Investigation results letter to be sent to representative and customer.We will notify appropriate personnel and will continue to monitor for similar complaints.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.H3 other text : blank fields on this form indicate the information is previously submitted, unknown, or unavailable investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control data, specifications, and visual inspection/ dimensional verification of the device was conducted during the investigation.Clinical assessment: the customer states, ¿the tip of the guide could no longer retract from the needle.¿ it is feasible to suggest the attempt to retract the wire through the needle contributed to the wire guide separation.Therefore, the probable cause of this event is user technique related.Two needle cannulas, a stiffening cannula, a trocar, and a wire guide were returned in a used condition.1 needle cannula and the stiffening cannula both contained a trocar in the lumen.The distal portion of the wire guide was unraveled with both the proximal and distal welds of the guide being found intact.The mandril diameter and the inner diameter of the needle cannula were both measured within specifications.It is likely that the wire guide became unraveled during removal from the needle cannula.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.Additionally, a search of the manufacturer's complaint database revealed no additional complaints have been reported for lot 8133562.Based on this information, the root cause of this complaint is likely use technique.It was stated that the customer could not retract the guide through the needle, which goes against the warning affixed to the wire guide holder stating that damage may occur if the wire guide is withdrawn through a needle.Investigation results letter to be sent to representative and customer.We will notify appropriate personnel and will continue to monitor for similar complaints.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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