It was reported, during an unknown procedure in which a cook silicone balloon hysterosalpingography injection catheter was used, that prior to patient contact, when filling the balloon it ruptured.It is unknown how the procedure was completed.It was reported that the patient did not experience any adverse effects due to this occurrence.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.
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Blank fields on this form indicate the information is unchanged, unknown or unavailable h6: ec method code desc - 5: communication/interview (4111).Investigation - evaluation.Reviews of complaint history, device history record, quality control data and the instructions for use(ifu) were conducted during the investigation.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows 1 other complaint associated with the complaint device lot.Due to the individual nature of the manufacturing and inspection process for the devices in the lots, it is unlikely that these events are an indication of device issue within the entire lot.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." the complainant did not return the complaint device to cook for investigation.At the time of the complaint investigation, all products in the complaint device lot have been distributed to customers, so no representative product is available from the lot for evaluation.The complaint was confirmed based on customer testimony.A definitive cause of the event could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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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