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

Catalog Number J-SOS-100500

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

E1: customer name and 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

As reported, during a cesarean section, the patient suffered a hemorrhage due to placenta previa.Prior to the bakri tamponade balloon catheter placement, oxytocin was given.The device was placed in the uterine cavity and was filled with 350ml of water.After placement, there was minimal vaginal bleeding, as well as a small amount of "dark red fluid" was found in the drainage bag.Five minutes after placement, the balloon shifted, and the amount of "pink liquid" increased in the drainage bag.The device was removed from the patient and filled with 350ml of water.The water flowed out of the drainage catheter.The device was not handled or in proximity to any metal tools.Prior to device failure, the estimated blood loss was 2000ml.After the device was placed, the estimated blood loss was 500ml.The total estimated blood loss was 2500ml.The procedure was completed with another company's uterine hemostatic balloon.The patient received a blood transfusion, but the hospital refused to provide the volume of blood.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during a cesarean section, the patient suffered a hemorrhage due to placenta previa.Prior to the bakri tamponade balloon catheter placement, oxytocin was given.The device was placed in the uterine cavity and was filled with 350ml of water.After placement, there was minimal vaginal bleeding, as well as a small amount of "dark red fluid" was found in the drainage bag.Five minutes after placement, the balloon shifted, and the amount of "pink liquid" increased in the drainage bag.The device was removed from the patient and filled with 350ml of water.The water flowed out of the drainage catheter.The device was not handled or in proximity to any metal tools.Prior to device failure, the estimated blood loss was 2000ml.After the device was placed, the estimated blood loss was 500ml.The total estimated blood loss was 2500ml.The procedure was completed with another company's uterine hemostatic balloon.The patient received a blood transfusion, but the hospital refused to provide the volume of blood.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures.Additionally, a visual inspection and functional test of the device was conducted.Two devices were returned in an unopened package with label, and one device was returned without package or label.All devices were function tested.The opened device was inflated without issue.The unopened devices were opened and inflated without issue.The complaint event could not be replicated with the returned devices.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records found four other complaints reported for the complaint device lot.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.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either in house or in the field.A review of relevant manufacturing and quality control documents was conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed product labeling; the ifu supplied with the device states the following in consideration of the reported failure mode: "upon removal from the package, inspect the product to ensure no damage has occurred." based on the available information, cook concluded a definitive cause of the event could not be determined.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, 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: 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: 18918525
• MDR Text Key: 337843790
• Report Number: 1820334-2024-00363
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)250805(10)14879146
• 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: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 14879146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2022
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 83 KG