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Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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, 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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Event summary: it was reported that during treatment of a postpartum hemorrhage, a bakri tamponade balloon catheter leaked.The operator inserted the device transvaginally into the patient and started inflation.Leaking was noted from the inflation valve port when the inflation volume reached 200ml.The patient lost a total of 1000ml of blood due to the hemorrhage.It is unknown how much blood was lost before or after placement of the device.The procedure was completed by using another new device.No adverse events to the patient have been reported as a result of the alleged malfunction.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.One bakri tamponade balloon catheter was returned for investigation.The device was returned in three separated pieces.Under magnification, a small puncture mark was observed in the balloon material.A document-based investigation evaluation was performed.No related nonconformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, "upon removal from the package, inspect the product to ensure no damage has occurred." although evaluation of the returned device indicates that balloon was likely punctured by an instrument during use, the customer has reported that no metal instruments were used with the device.Cook could not determine a definitive cause of this event from the available information.Cook will continue monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering 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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