MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; OQY INTRAUTERINE BALLOON

Catalog Number J-SOSR-100500

Device Problem Deflation Problem (1149)

Patient Problem Hypovolemic Shock (1917)

Event Type  Injury  

Manufacturer Narrative

Initial reporter:(b)(6).Pma/510k # k170622.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.(b)(4).

Event Description

It is reported that during treatment of post-partum hemorrhage with a cook bakri postpartum balloon with rapid instillation components, the patient experienced uterine perforation and accompanying hemoperitoneum of 2700ml with active bleeding noted.Patient was a (b)(6) female, para 3, with no history of abdominal surgery, cesarean delivery or post-partum hemorrhage.Eleven minutes after delivering a (b)(6) female infant by unspecified mode of delivery, the patient was diagnosed with post-partum hemorrhage.Uterine and vaginal inspection revealed a right lateral vaginal and cervical laceration, as well as uterine atony.The lacerations were successfully sutured.The oxytocin infusion was stopped and replaced with sulprostone at an unspecified rate of infusion.It is unclear how long, and at what dose/rate oxytocin had been infusing prior to being stopped.A bakri balloon® was successfully placed under general anesthesia and to 500 ml under manual and ultrasound guidance.The bleeding stopped shortly after inflation.Blood loss up to the point was recorded as 1400ml.Five hours and 45 min later, the bakri balloon was deflated to 400 ml due to pelvic pain unrelieved by intravenous painkillers.Hemoglobin level was 10 g/dl.The bakri balloon® bag was filled with 75 ml of blood, without any active bleeding.Ultrasound control did not observe any abnormality.Blood pressure and heart rate where normal.Explorative laparotomy was then performed concomitantly with resuscitation.Intraperitoneal exploration was hindered by the amount of blood present in the peritoneum (2700ml) accompanied by active bleeding.The bakri balloon was found deflated into the abdominal cavity.Exploration revealed laceration of the right broad ligament and an anterior uterine perforation.The right uterine and cervico-vaginal arteries where bleeding.Dissections and hemostasis was particularly difficult, due to significant pelvic tissue edema.Ligations of the uterine vessels and the cervico-vaginal artery were performed, as well as suture of the uterine rupture.Hysterectomy was considered, but it was determined that there would be no additional benefit, and due to the edematous pelvic tissue, there was concern that this would cause more bleeding, therefore it was not performed.Concomitant resuscitation included: 11 units of packed red blood cells (prbcs), 9 units of fresh frozen plasma, 2 units of platelets, 2 gm.Of tranexamic acid, 8 gm.Of fibrinogen, 2 units of sulprostone, and 24 h of intravenous norepinephrine.The lowest hemoglobin recorded was at 7.9 g/dl, during the surgery.After biologic stabilization, the patient was able to leave intensive care unit the day after her admission.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation the complaint device was not returned for an evaluation and no photographs were provided.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, manufacturing instructions, quality control data, and trends.A review of the device history record could not be performed as the lot number of the device was not provided.A review of complaint history on the complaint device lot could not be performed because the lot number was not available.Clinical assessment: discussion of this case touches on the events leading up to the rupture.Insertion and inflation of the bakri balloon was done under ultrasound without any indication of incorrect placement.Two ultrasounds were performed prior to deflation to 400cc without any perforation noted.The only noted sign was pain.It was the belief of the author that the rupture likely occurred during dilation and the internal bleeding rapidly occurred when the balloon was partially inflated (deflated) to 400cc due to patient¿s pain.It is not known how long and at what rate oxytocin had been infusing before it was stopped, which could be a contributing factor to the uterine atony.The causes of bakri migration and deflation are not known.It is not known if counter pressure was used to prevent displacement.The uterine and vaginal inspections revealed a right lateral vaginal and cervical laceration but little is known regarding the extent.Uterine perforation is a known inherent risk of this device that could result in critical harm.The instructions for use (ifu) that accompanies this device provides the following information to the user related to the reported failure mode: warnings 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.The device should not be left indwelling for more than 24 hours.The balloon should be inflated with a sterile liquid such as sterile water, sterile saline, or lactated ringers solution.The balloon should never be inflated with air, carbon dioxide or any other gas.The maximum inflation is 500ml.Do not overinflate the balloon.Overinflation of the balloon may result in the balloon being displaced into the vagina.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 of dic.Patient monitoring is an integral part of managing postpartum hemorrhage.Signs of deteriorating or non-improving condition should lead to a more aggressive treatment and management of patient uterine bleeding.Patient uterine output should be monitored while the bakri postpartum balloon is in use.Precautions this product is intended for use by physicians trained and experienced in obstetrics and gynecological techniques.Avoid excessive force when inserting the balloon into the uterus.Instructions to prevent displacement of the balloon into the vagina, counter pressure can be applied by packing the vaginal canal with iodine- or antibiotic-soaked vaginal gauze.Probable causes of this event include device failure, medical procedure, and patient anatomy related, but at this time the actual cause of the event is unknown.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Monitoring will continue to be performed for similar complaints.The appropriate cook personnel have been notified of this event.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.

Event Description

There has been no new event information received since the last report was submitted.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8267057
• MDR Text Key: 133727216
• Report Number: 1820334-2019-00199
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 39 YR