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

Model Number G24237

Device Problem Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter name and address: customer postal code: (b)(6), customer phone: (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, a cook bakri postpartum balloon with rapid instillation components was used to treat postpartum hemorrhage (pph).The balloon appeared to be working at first, but then the customer noticed the balloon was leaking fluid.The device eventually deflated.Another device of the same type was used to treat the postpartum hemorrhage.Additional information has been requested but is not available at this time.

Manufacturer Narrative

Summary of event: as reported, a cook bakri postpartum balloon with rapid instillation components was used to treat postpartum hemorrhage (pph).Approximately 1.5 hours post vaginal delivery, the patient had lost over 1500ml of blood; 2 units of packed red blood cells (prbc) were transfused and a 'cook bakri postpartum balloon with rapid instillation components' was deployed.The balloon was inflated with 250ml fluid then the device spontaneously deflated.The device was then reinserted and inflated with 200ml fluid when leaking from the device was noted.The patient had an additional 300-500ml blood loss after device failure.The patient had a total estimated blood loss (ebl) of 2000ml.Another ¿cook bakri postpartum balloon with rapid instillation components¿ was deployed to complete the procedure and hemostasis was achieved.At an unknown point in the procedure, sponge sticks were used to stabilize the cervix, and intramyometrial (imm) hemabate was injected into the myometrium used to treat the postpartum hemorrhage.Investigation evaluation: a document-based investigation evaluation was performed.Reviews of the complaint history, device history record, instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.A complaint history database search showed no other related complaints associated with the complaint device lot 14977014.A search of the complaint database [device history record] found no related non-conformances.Document review did not indicate that the device was manufactured out of specifications and does not suggest items in the lot or similar devices in the field or in house are nonconforming.Functional testing and visual inspection of the returned complaint devices was also conducted.One used device was returned and evaluated by a quality engineer.According to the device failure analysis, the device was inflated with water and no leakage was observed; the reported failure mode could not be replicated or confirmed.Based upon the available information and results of the investigation, cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering 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.

Event Description

Additional information received 13mar2023.Approximately 1.5 hours post vaginal delivery, the patient had lost over 1500ml of blood; 2 units of packed red blood cells (prbc) were transfused and a 'cook bakri postpartum balloon with rapid instillation components' was deployed.The balloon was inflated with 250ml fluid then the device spontaneously deflated.The device was then reinserted and inflated with 200ml fluid when leaking from the device was noted.The patient had an additional 300-500ml blood loss after device failure.The patient had a total estimated blood loss (ebl) of 2000ml.Another ¿cook bakri postpartum balloon with rapid instillation components¿ was deployed to complete the procedure and hemostasis was achieved.At an unknown point in the procedure, sponge sticks were used to stabilize the cervix, and intramyometrial (imm) hemabate was injected into the myometrium used to treat the postpartum hemorrhage.

• 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: 16419318
• MDR Text Key: 310334435
• Report Number: 1820334-2023-00172
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)250927(10)14977014
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 14977014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• 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 Sex: Female