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

Model Number N/A

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2023

Event Type  Injury  

Manufacturer Narrative

E1: customer street (b)(6).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.

Event Description

As reported, the balloon of a 'cook bakri postpartum balloon with rapid instillation components' ruptured during use.The patient underwent a cesarean section due to a placental abruption.Following delivery of the placenta, 4-5 blood clots were noted on the placental surface and the patient experienced uterine atony and a blood loss of ~2000ml.The bakri device was inserted into the uterus and the balloon was inflated with 400ml normal saline.It was then noted that the fluid was continuously flowing out of the balloon and vagina during attempted inflation.The device was removed and it was noted that the balloon had ruptured.The new bakri device was used to complete the procedure.The patient lost an additional ~100ml of blood following the device issue; total estimated blood loss was ~2100ml.The patient was transfused with 6 units of red blood cells, 800ml plasma, and 10 units of 'cryoprecipitate'.It was reported that the device did not come into contact with any metal tools.The balloon was not inflated prior to the closure of the hysterotomy.A section of the device did not remain inside the patient¿s body.The patient did not require any other additional intervention due to this occurrence.The patient did not experience any other adverse effects due to this occurrence.

Manufacturer Narrative

Event description: as reported, the balloon of a 'cook bakri postpartum balloon with rapid instillation components' ruptured during use.The patient underwent a cesarean section due to a placental abruption.Following delivery of the placenta, 4-5 blood clots were noted on the placental surface and the patient experienced uterine atony and a blood loss of 2000 ml.The bakri device was inserted into the uterus and the balloon was inflated with 400 ml normal saline.It was then noted that the fluid was continuously flowing out of the balloon and vagina during attempted inflation.The device was removed and it was noted that the balloon had ruptured.The new bakri device was used to complete the procedure.The patient lost an additional 100 ml of blood following the device issue; total estimated blood loss was 2100 ml.The patient was transfused with 6 units of red blood cells, 800 ml plasma, and 10 units of 'cryoprecipitate'.It was reported that the device did not come into contact with any metal tools.The balloon was not inflated prior to the closure of the hysterotomy.A section of the device did not remain inside the patient¿s body.The patient did not require any other additional intervention due to this occurrence.The patient did not experience any other adverse effects due to this occurrence.Investigation ¿ evaluation: reviews of complaint history, device history record (dhr), 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.There is no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows one other complaint associated with the complaint device lot for balloon leakage.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.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that the device was manufactured to specification and there is no evidence that nonconforming product exists in house or in the field.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.The instructions for use (ifu), 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." 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.The appropriate 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.

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: 17777041
• MDR Text Key: 323767082
• Report Number: 1820334-2023-01260
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: N/A
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 13449177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• 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): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 56 KG