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

Catalog Number J-SOSR-100500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Uterine Perforation (2121)

Event Date 08/04/2020

Event Type  Injury  

Event Description

As reported in a literature complaint, a patient was transferred from an outside hospital 12 hours after delivery for treatment of postpartum hemorrhage.The hemorrhage was being managed with uterotonic, dilation and curettage (d&c), and the placement of a 'cook bakri postpartum balloon with rapid instillation components' and vaginal packing.An unknown amount of time after transfer, the patient reported severe abdominal pain and a ct scan was performed.The ct revealed the tip of the bakri was outside of the uterus.A laparotomy was performed and confirmed the bakri tip was in the broad ligament.The device was deflated and removed.It was reported that the patient had no other internal injuries and an uneventful recovery.In a follow-up letter to the editor, the authors indicated that the uterine perforation may have been caused either by the dilation and curettage (d&c) that was performed immediately prior to placement of the bakri balloon and is known to carry an increased risk of uterine perforation or during insertion or inflation of the bakri balloon at the initial facility, however, the authors reported that they believe this is unlikely.The authors could not be certain of the exact cause of the perforation in this case, but believed that ultrasound guidance during bakri balloon placement would help with early identification and management of perforations in future cases.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Reference for literature article: spencer, n.R.& saad, a.(2020).Perforation with bakri balloon into broad ligament during management of postpartum hemorrhage.American journal of obstetrics & gynecology.Https://doi.Org/10.1016/j.Ajog.2020.07.052 reference for letter to the editor associated with literature article: spencer, n.R.& saad, a.(2021).How did a bakri balloon enter the broad ligament? american journal of obstetrics & gynecology.Https://doi.Org/10.1016/j.Ajog.2021.08.019 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.

Manufacturer Narrative

Event description: as reported in a literature complaint, a patient was transferred from an outside hospital 12 hours after delivery for treatment of postpartum hemorrhage.The hemorrhage was being managed with uterotonic, dilation and curettage (d&c), and the placement of a 'cook bakri postpartum balloon with rapid instillation components' and vaginal packing.An unknown amount of time after transfer, the patient reported severe abdominal pain and a ct scan was performed.The ct revealed the tip of the bakri was outside of the uterus.A laparotomy was performed and confirmed the bakri tip was in the broad ligament.The device was deflated and removed.It was reported that the patient had no other internal injuries and an uneventful recovery.In a follow-up letter to the editor, the authors indicated that the uterine perforation may have been caused either by the dilation and curettage (d&c) that was performed immediately prior to placement of the bakri balloon and is known to carry an increased risk of uterine perforation or during insertion or inflation of the bakri balloon at the initial facility, however, the authors reported that they believe this is unlikely.The authors could not be certain of the exact cause of the perforation in this case, but believed that ultrasound guidance during bakri balloon placement would help with early identification and management of perforations in future cases.Investigation / evaluation: reviews of instructions for use (ifu) and quality control procedures were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document-based investigation evaluation was performed.The available evidence suggests that the device was manufactured to specification.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of complaint history records could not be completed due to lack of lot information from the user facility.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: contraindications: a surgical site that would prohibit the device from effectively controlling bleeding.It was reported that the patient underwent a dilation and curettage (d&c) procedure immediately prior to device placement.Instructions for use: the ifu warns, the maximum inflation is 500ml.Do not overinflate the balloon.Over inflation of the balloon may result in the balloon being displaced into the vagina.It is unknown how much was used to inflate the balloon.Important: prior to transvaginal or transabdominal placement of the bakri postpartum balloon, the uterus should be free of all placental fragments, and the patient should be evaluated to ensure that there are no lacerations or trauma to the genital tract and that the source of the bleeding is not arterial.Transvaginal placement: 1.Determine uterine volume by direct examination or ultrasound examination.Transabdominal placement, post-cesarean section: balloon inflation: once the balloon has been inflated to the predetermined volume, confirm placement via ultrasound.Note: ultrasound should be used to confirm proper placement of the balloon once the balloon is inflated to the predetermined volume.It was not reported that any scan to confirm placement was performed after device placement.It was only reported that a ct scan was performed an unknown amount of time after placement due to the patient reporting abdominal pain.A definitive cause of the event could not be determined from the available information.Per the quality engineering risk assessment, no further action is required.We will continue to monitor for similar complaints.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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 18276579
• MDR Text Key: 329852784
• Report Number: 1820334-2023-01646
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Sex: Female