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 Problems Anxiety (2328); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2024

Event Type  Injury  

Event Description

As reported, the balloon of a 'cook bakri postpartum balloon with rapid instillation components' ruptured during use.The device was placed transvaginally following a vaginal delivery for treatment of postpartum hemorrhage, secondary to uterine atony, and the patient was continuously monitored.It was reported that during monitoring, 500ml of fluid was observed in the collection bag.Upon ultrasound, the uterine void line was noted; however, the uterus was empty and the bakri device could not be seen in the uterus.The device was then removed and it was noted that the device was deflated and a 5cm tear was found in the balloon material.Upon removal, the estimated 500ml of fluid in the drainage bag corresponded to the saline solution used to inflate the device, rather than blood.The patient's total estimated blood loss from the perineal wound and uterine atony was 1500ml.The patient had no externalized bleeding following device removal.Hemostasis was achieved without the use of a second device.The patient received 2 units of concentrated red blood cells (cgr's).The device did not come into contact with any metal tools.No other adverse effects were reported for this incident.

Manufacturer Narrative

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

It was reported that the patient experienced anxiety due to the suspected heavy bleeding.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: b5, h6 (annex e) 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 or that a death or serious injury occurred; nor is it admission 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

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.As reported, the balloon of a 'cook bakri postpartum balloon with rapid instillation components' ruptured during use.The device was placed transvaginally following a vaginal delivery for treatment of postpartum hemorrhage, secondary to uterine atony, and the patient was continuously monitored.It was reported that during monitoring, 500ml of fluid was observed in the collection bag.Upon ultrasound, the uterine void line was noted; however, the uterus was empty and the bakri device could not be seen in the uterus.The device was then removed and it was noted that the device was deflated and a 5cm tear was found in the balloon material.Upon removal, the estimated 500ml of fluid in the drainage bag corresponded to the saline solution used to inflate the device, rather than blood.The patient's total estimated blood loss from the perineal wound and uterine atony was 1500ml.The patient had no externalized bleeding following device removal.Hemostasis was achieved without the use of a second device.The patient received 2 units of concentrated red blood cells (cgr's).The device did not come into contact with any metal tools.The patient experienced anxiety due to the suspected heavy bleeding.No other adverse effects were reported for this incident.A document-based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures for the device.The complaint device was not returned; therefore, no physical examinations could be performed.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-sosr_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 root cause was unable to be established.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.

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: 18905694
• MDR Text Key: 337684594
• Report Number: 1820334-2024-00347
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)250801(10)14869327
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 14869327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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 Age: 27 YR
• Patient Sex: Female