MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; OQY INTRAUTERINE BALLOON

Model Number G30673

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Insufficient Information (4580)

Event Date 07/14/2022

Event Type  malfunction  

Manufacturer Narrative

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.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

As reported, after a cesarean section (c-section) delivery, a bakri tamponade balloon catheter was used to treat postpartum hemorrhage (pph).The device was inserted into the patient and balloon was inflated.At the end of the intervention it was noted that the fluid collection bag was slowly filling with a liquid slightly mixed with blood and leakage from the balloon was suspected.The balloon was removed and there were no visible leaks or holes found in the balloon.The balloon was inflated and water was found to be leaking into the tube that is supposed to divert the blood from the uterus.Total blood loss was estimated at 2000-2500 ml.No adverse effects to the patient have reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, b7, h6: health effect - clinical code (annex e), and health effect - impact code (annex f) event summary as reported, after a cesarean section (c-section) delivery, a bakri tamponade balloon catheter was used to treat postpartum hemorrhage (pph).The patient had placenta previa.After delivery, the lower segment of the uterus did not contract well and the patient was bleeding heavily and lost 2250 ml of blood.The patient received three units of blood and uterotonic prior to device placement.The balloon was placed trans-abdominally and filled with 350ml of saline after closure of the uterotomy.The uterus was well contracted and the abdomen was closed.After the surgery was completed, a lot of fluid mixed with blood was observed draining into the output collection bag.The balloon was removed, and it was deflated without visible leaks in the balloon material.The balloon was inflated and water was found to be leaking into the tube that is supposed to divert the blood from the uterus.A new balloon was placed vaginally and used to successfully achieve hemostasis.The patient did not bleed much following the difficulty with the balloon, but she did get low blood pressure when she was put in the lithotomy position.The total blood loss was estimated to be 2250-2500 ml.No other adverse effects were reported.Investigation ¿ evaluation reviews of the complaint history, device history record, instructions for use, and quality control procedures were conducted during the investigation.The device was not returned to cook for investigation.A document-based investigation evaluation was performed.A review of the device history record found no related non-conformances were recorded.No additional complaints were received for this product lot.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot 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 device is provided with instructions for use which state how the device is supplied, "upon removal from the package, inspect the product to ensure no damage has occurred." based on the available information, cook concluded the most probable cause of the reported event was determined to be lumen communication, although the cause of the lumen communication could not be determined from the available information.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.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 was received (b)(6) 2023: as reported, the patient had placenta previa.After a cesarean section (c-section) delivery, the lower segment of the uterus did not contract well and the patient was bleeding heavily and lost 2250 ml of blood.The patient received three units of blood and uterotonic prior to device placement.The balloon was placed trans-abdominally and filled with 350ml of saline after closure of the uterotomy.The uterus was well contracted and the abdomen was closed.After the surgery was completed, a lot of fluid mixed with blood was observed draining into the output collection bag.The balloon was removed, and it was deflated without visible leaks in the balloon material.The balloon was inflated and water was found to be leaking into the tube that is supposed to divert the blood from the uterus.A new balloon was placed vaginally and used to successfully achieve hemostasis.The patient did not bleed much following the difficulty with the balloon, but she did get low blood pressure when she was put in the lithotomy position.The total blood loss was estimated to be 2250-2500 ml.No other adverse effects were reported.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• 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: 16272033
• MDR Text Key: 308564409
• Report Number: 1820334-2023-00081
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)241026(10)14308042
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 14308042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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 Sex: Female