E1: customer (person): line 2: (b)(6).Phone: (b)(6).Additional phone: (b)(6).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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event summary: it was reported that the outer sheath in an ultraxx nephrostomy balloon and set could not advance over the inflated balloon catheter smoothly during a percutaneous nephrostomy procedure in an unknown patient.It is unknown if the customer attempted to reduce the pressure of the balloon.The procedure was completed with a percutaneous renal dilator.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation ¿ evaluation: a document-based investigation was performed including a review of complaint history, device history record (dhr), and quality control procedures, as well as a visual inspection and functional test of the device were conducted.The device was returned to cook for evaluation and an inspection.A function test was performed with the returned cook inflation device, and there was no noted inflation issue.The sheath was attempted to be slid over the balloon at inflation pressures of 20, 15, 12, and 10 atm.Only once the pressure was decreased to 10 atm was the sheath able to fully advance over the balloon.There is no evidence to suggest that the product was not manufactured to the appropriate specifications.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device revealed no recorded non-conformances relevant to the failure mode.A historic lot search was also conducted, and one additional customer complaint has been received for the reported device lot.The additional complaint was for the same issue and was reported by the same customer.Due to the inspection methods and individual manufacturing nature of these devices, it is unlikely that these two complaints signify an issue with the entire lot of nephrostomy balloon sets.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook was unable to review the product labeling for this device as the lot was exempted from an ifu due to the destination country.Based on the information provided, inspection of the returned device, and the results of the investigation, the cause for this complaint was unable to be determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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