It was reported an ultrathane cope nephroureterectomy stent was placed in a patient during the "summer" of 2018.An unspecified amount of time after placement, the catheter was found to be leaking at the connection between the catheter and the hub.It is unknown if the catheter was replaced.Additional information regarding the event, patient demographics, and patient outcome has been requested but is currently unavailable.
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Investigation ¿ evaluation a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device was 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 one nonconforming event which could contribute to this failure mode; however, there is 100% inspection for this prior to lot release and all identified devices were scrapped out.It should be noted there were two other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be established.Measures are being conducted to address this failure mode.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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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Additional information: patient code: 3191 [no code available]- additional procedure required to replace device additional information was received from the customer on (b)(6) 2018.This information described the specific event and patient information.It was reported the patient had an ultrathane cope nephroureterostomy stent placed in the kidney to drain urine.Thirteen days later, the drain was exchanged due to leaking at the hub of the catheter.This exchange is recorded under this medwatch report (1820334-2018-03341).The replacement drain was also found to be leaking at the hub and was exchanged 27 days later.This second exchange is recorded under medwatch report #1820334-2018-03549.As reported, the patient did not experience any other adverse effects due to this occurrence.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.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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