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Blank fields on this form indicate the information is unknown or unavailable.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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It was reported that during a treatment of postpartum hemorrhage, secondary to uterine inertia/atony, a bakri tamponade balloon catheter's balloon ruptured.Post cesarean section, the balloon was placed in patient's vagina and was initially inflated with 200ml fluid.Another 50ml fluid was used to further inflate the balloon, upon which it was noticed that the fluid was leaking out of the vagina.The balloon was retracted, and the rupture was detected, however the picture provided for the device suggests a pinhole leak.The packaging of the balloon was intact, and the device was not handled by or in the proximity of any metal tools.Another same type device was used to complete the procedure.The total estimated blood loss was 440ml, with 380ml occurring before device use and an additional 60ml afterwards.No blood transfusions were required.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation it was reported that during a treatment of postpartum hemorrhage, secondary to uterine inertia/atony, a bakri tamponade balloon catheter's balloon ruptured.Post cesarean section, the balloon was placed in patient's vagina and was initially inflated with 200ml fluid.Another 50ml fluid was used to further inflate the balloon, upon which it was noticed that the fluid was leaking out of the vagina.The balloon was retracted, and the rupture was detected, however the picture provided for the device suggests a pinhole leak.The packaging of the balloon was intact, and the device was not handled by or in the proximity of any metal tools.Another same type device was used to complete the procedure.The total estimated blood loss was 440ml, with 380ml occurring before device use and an additional 60ml afterwards.No blood transfusions were required.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection and functional test of the returned device were conducted during the investigation.The bakri tamponade balloon catheter was returned to cook for evaluation.Function testing revealed a pinhole leak in the balloon material.Visual inspection noted tool marks in the balloon material near the area of the hole.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 lot revealed no recorded non-conformances relevant to the failure mode.A database search identified one other complaint associated with the reported 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.Review of the device history record, complaint history, quality control documents, and device failure analysis does not indicate that the device was manufactured out of specification and does not suggest items in the lot or similar devices in the field or in house are nonconforming.Cook also reviewed product labeling.The product ifu, t_j-sosr_rev4 ¿bakri postpartum balloon,¿ provides the following information to the user related to the reported failure mode: how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." based on the information provided, inspection of the returned device, and the results of the investigation, a definitive cause of the event could not be determined from the available information.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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