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As reported, a 'bakri tamponade balloon catheter' was used for treatment of postpartum hemorrhage (pph) following a cesarean section delivery.During attempted inflation of 50ml, it was noted that the balloon would not inflate and fluid was leaking out of the vagina.The device was removed and found that the balloon had ruptured.The procedure was completed using a new device.Total estimated blood loss was ~800-830ml.The patient did not require any blood transfusions.The device was handled in the proximity of forceps and/or suture needles during use.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
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Blank fields on this form indicate the information is unknown or unavailable.E1: (b)(6).E3: customer occupation = unknown.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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Investigation ¿ evaluation: as reported, a cook bakri postpartum balloon was used following a cesarean delivery and postpartum hemorrhage of 800ml.Forceps and suture needles were used in the procedure.The bakri balloon was placed, and was found to not inflate after injecting 50 ml.Liquid was observed flowing out of the patient's vagina.The balloon was removed and found to be ruptured.Hemostasis was achieved with another new balloon.The total estimated blood loss was 830 ml.Blood transfusions were not needed.No adverse effects were reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.The complaint device was returned for evaluation.Visual inspection observed a hole in the balloon material.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr) which records no relevant non-conformances.A database search for complaints on the reported lot found one additional complaint for "balloon leakage" reported from the field.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.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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