As reported, during a mini percutaneous nephrolithotomy, water leaked from the balloon body on an ultraxx nephrostomy balloon.The leak was noted prior to patient contact and the procedure was completed with a new same type device.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to the occurrence.According to the initial reporter, the patient did not experience any adverse effects.
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Correction: this report is being sent to indicate the complaint event is not reportable under fda 21 cfr part 803.Upon further investigation, this event is not reportable.This event does not meet the criteria for a serious injury.An mdr guidance for manufacturers issued in 1997 stated that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established.This presumption will continue until either the malfunction has caused or contributed to no further deaths or serious injuries for two years, or the manufacturer can show through valid data that the likelihood of another death or serious injury as a result of the malfunction is remote.A detailed review of complaint history using a validated report revealed that there have been no deaths or serious injuries, per 21 cfr part 803.3, due to a ultraxx balloon catheter¿s balloon material being compromised (rupture/burst, pinhole, cut, etc.), from 01jan2019 through 10aug2022.Therefore, cook will cease malfunction reporting for events where a ultraxx balloon catheter¿s balloon material was compromised (rupture/burst, pinhole, cut, etc.).The recurrence of a serious injury or death for the same malfunction will trigger the resumption of mandatory reporting, per 21 cfr part 803.50.As such, this event no longer meets the set criteria for a reportable event; no further reports regarding this event will be submitted.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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