It was reported, during a uterine cavity procedure using a cook silicone balloon hysterosalpingography injection catheter, the balloon burst.The doctor was attempting to inflate the balloon with 1.5 ml of nacl (sodium chloride), but the balloon burst when it was filled with only 1.4 ml nacl.The procedure was completed when they "took another hsg catheter".No adverse events have been reported due to the alleged malfunction.Additional details have been requested regarding the patient and event.At this time no additional information has been provided.
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Blank fields on this form indicate the information is unchanged, unknown or unavailable investigation - evaluation reviews of instructions for use (ifu), trends, 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 could not be completed due to lack of lot information from the user facility.A search for other complaints associated with the complaint device lot number could not be completed due to lack of lot information from the user facility.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: precautions "do not overinflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture." "refer to product label of the inflation check valve on the balloon device for appropriate balloon volume." how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." no device was returned for evaluation.There is no indication that a design related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The complaint was confirmed based on customer testimony.A definitive root cause of the events could not be determined.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue to monitor for similar complaints.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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