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A letter to the editor was reviewed: "a (b)(6) multiparous woman underwent ultrasound guided suction evacuation of her uterus for secondary postpartum haemorrhage, two weeks after a normal vaginal delivery.However, ongoing heavy bleeding was noted in the recovery room and she was taken back to the operating theatre.A laparoscopy was performed to rule out uterine perforation.Bleeding did not abate with repeat curettage.Hence, a bakri tamponade balloon catheter was inserted and inflated with 500mls saline under laparoscopic guidance.She appeared to have stabilized and was transferred to the ward.She deteriorated a few hours later, becoming hypotensive and tachycardic.The fundus appeared to have risen but there was no external bleeding.The bakri bag had collected 400mls blood over the first four hours but no further output after that.Bedside ultrasound suggested large blood clots in the uterus above the balloon.Despite replacement of losses, her haemoglobin level had fallen to 53mg/dl and she was developing disseminated intravascular coagulation.About 12 h after insertion of bakri balloon, she was taken back to the operating theatre for a laparotomy.At laparotomy, bakri balloon was noted to have perforated through the anterior lower segment of uterus.(the patient had never had a caesarean or uterine surgery).Fresh bleeding from the uterine edge was noted and 500mls of blood clot were seen in the fundus of uterus, above the balloon.Tissues were noted to be friable due to possible infection, though no malodorous discharge was noted.A postpartum hysterectomy was performed.The total estimated blood loss was 2.7 liters and the patient received 15 units of blood and blood products.She made a slow recovery with a return to theatre six days later to drain a pelvic collection.The letter to the editor further states: "we have identified three additional cases of migration of bakri balloon through the uterus, all in the context of secondary post-partum haemorrhage (table 1).Hysterectomy was required in all three cases.It is possible that the infected nature of the tissue and smaller capacity of uterus, in this scenario, make it more prone to perforation from an intraluminal balloon.Unlike the previous cases, our insertion of bakri balloon was under laparoscopic guidance; hence it is certain that the perforation occurred after the balloon was inserted and inflated." for the following three patients the device was used 15-25 days post delivery, contrary to one of the warnings listed in the instructions for use (ifu).Patient 1 was treated at 15 days post-delivery with a prior uterine surgery (c-section) using a bakri balloon inflated with 500ml saline.Laparotomy findings included fundal rupture with placenta "acreta".Patient 2 was treated at 18 days post-delivery with no prior uterine surgery using a bakri balloon inflated with 500ml saline (guided).Laparotomy findings stated that the bakri migrated to left broad ligament.Patient 3 was treated at 25 days post-delivery with no applicable prior uterine surgery using a bakri balloon inflated with 250ml saline.Laparotomy findings were a 5cm fundal tear.Srilehka, deepika, sunith, & venkateshwari, 2018, p.203-204.The ifu that ships with this device, under "warnings", contains the following: "the bakri postpartum balloon is indicated for use in the event of primary postpartum hemorrhage within 24 hours of delivery." disseminated intravascular coagulation is listed under the contraindications section of the ifu.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 unknown, unchanged, or unavailable.Investigation ¿ evaluation the complaint device was not returned for an evaluation.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of drawings, the instructions for use, quality control data, and specifications.A review of the device history record was unable to be performed as the complaint device lot number was not provided.A review of complaint history for the complaint device lot number could not be performed without the complaint device lot number.The instructions for use (ifu) provides the proper warnings, precautions, and instructions for use.As provided in the warnings section: this device is intended as a temporary means of establishing hemostasis in cases indicating conservative management of postpartum uterine bleeding.The bakri postpartum balloon is indicated for use in the event of primary postpartum hemorrhage within 24 hours of delivery.Patients in whom this device is being used should be closely monitored for signs of worsening bleeding and/or disseminated intravascular coagulation (dic).In such cases, emergency intervention per hospital protocol should be followed.There are no clinical data to support use of this device in the setting if dic.Patient uterine output should be monitored while the bakri postpartum balloon is in use.A review of this literature has also identified three additional cases of the bakri balloon migrating through the uterus.In each case, these events are associated with the use of the device in contradiction with ifu.The literature stated that the device was used at least one week after each patient had given birth.The customer could not give any lot numbers or the complaint device rpn.However, it is assumed that the complaint rpn is a (b)(4).During the investigation evaluation, a review of the current versions governing the manufacturing and quality controls was performed.This review found that current process and quality inspection checks are in place to ensure the functionally and device integrity prior to shipment.No specific issue with this documentation was identified that may have contributed to this failure mode.The cause for this specific failure mode is likely related to the use of the device in contradiction of the ifu.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and we will continue to monitor 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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