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

Catalog Number J-SOSR-100500

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2024

Event Type  Injury  

Event Description

As reported, the 'cook bakri postpartum balloon with rapid instillation components' "broke" causing the balloon to not inflate.Approximately 2 hours after a vaginal delivery, the patient experienced postpartum hemorrhage [pph], secondary to uterine atony.The patient was administered vasopressors, norepinephrine, an oxytocic drip, 1g tranexamic acid, first dose of methylergometrine and globular concentrate; the patient's vitals were taken and the uterine cavity was assessed for bakri device insertion.The user injected 300cc of saline into the balloon but found that it was not inflating.The user removed the balloon and found that it was "broken".The balloon was removed after approximately 10 seconds and the patient was taken to the operating room for an emergency abdominal hysterectomy.The patient had an estimated blood loss (ebl) of 3000cc.The patient received 9 units of globular concentrate, 4 units of plasma, and 1 unit of platelets.The patient was then discharged from the hospital in good general condition and hemodynamically stable.The device was not tested prior to use.The device was not handled by or in the proximity of any metal tools.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: customer address = (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

Additional information received 24apr2024: the total blood lost was 3300cc.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information/corrections: h6 (annex e).Investigation ¿ evaluation as reported, the 'cook bakri postpartum balloon with rapid instillation components' "broke" causing the balloon to not inflate.Approximately 2 hours after a vaginal delivery, the patient experienced postpartum hemorrhage [pph], secondary to uterine atony.The patient was administered vasopressors, norepinephrine, an oxytocic drip, 1g tranexamic acid, first dose of methylergometrine and globular concentrate; the patient's vitals were taken and the uterine cavity was assessed for bakri device insertion.The user injected 300cc of saline into the balloon but found that it was not inflating.The user removed the balloon and found that it was "broken".The balloon was removed after approximately 10 seconds and the patient was taken to the operating room for an emergency abdominal hysterectomy.The patient had an estimated blood loss (ebl) of 3300cc.The patient received 9 units of globular concentrate, 4 units of plasma, and 1 unit of platelets.The patient was then discharged from the hospital in good general condition and hemodynamically stable.The device was not tested prior to use.The device was not handled by or in the proximity of any metal tools.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control, 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.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other complaints associated with the reported device lot.Review of the device history record, complaint history, and quality control documents 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-sos_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 available information, no product returned, 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.

• 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: 19147173
• MDR Text Key: 340675269
• Report Number: 1820334-2024-00556
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)260821(10)15620478
• 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: 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 15620478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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: 21 YR
• Patient Sex: Female
• Patient Weight: 62 KG