It is reported during ureteroscopy using a roadrunner nimble hydrophilic wire guide, the collecting system was perforated and contrast media extravasation occurred.It should be noted that the wire guides were being used for the first time.This happened in 4 cases.(the 3 other cases are reported in patient identifier (b)(6), patient identifier (b)(6), and patient identifier (b)(6).There were no additional consequences to the patient.The patient did not require any additional procedures as a result of this occurrence.
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Investigation/evaluation: reviews of complaint history, device history record, documentation, drawings, specifications, and quality control data 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 found no non-conformances related to the reported failure mode.A review of complaint history records shows 3 other complaints associated with the complaint device lot, all of which were the complaints associated with this complaint.Since adequate inspection activities are in place, there have been no other reported non-conformances, and no complaints on the device lot outside of the user facility, cook has concluded that there is no evidence to suggest there is any nonconforming product in house or out in the field.The device is not supplied with specific instructions for use.The customer stated that the wire guides did not seem flexible enough, which caused perforation of the collecting system upon use.The devices were not returned for investigation, however, so there is no evidence to suggest the wire guides were not manufactured correctly.The wire guides are loaded into the spiral holder with the stiff end first.It is possible that the wires were not inserted correctly during manufacturing, causing the user to insert the stiff end into the patient first.This could have led to the perforation of the patient anatomy.It is also possible that the user removed the wire guide from the holder, and inserted the wrong end into the patient first.It is also possible that the wire guide was inserted correctly, but the user used excessive force upon insertion, leading to perforation.It is unknown what other components were used with the wire guide during the procedure, but it is also possible that another component caused the perforation, but was not observed right away.Cook has concluded that a definitive cause for the failure mode could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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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