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

Model Number G30673

Device Problem Failure to Deflate (4060)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/10/2022

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Device evaluated by mfg = other.Device returned and preliminary device failure analysis performed (b)(6) 2022.Final device evaluation summary will be submitted on a subsequent mdr when complete.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 a bakri tamponade balloon catheter could not be deflated during use.The user placed the device transvaginally for treatment of postpartum hemorrhage.The balloon was placed and inflated by injecting 100ml of distilled water.The user then attempted to remove the water to deflate the balloon in order to reposition the device; but the water could not be removed.The user then pulled the device out with the balloon still inflated and replaced it with another balloon catheter with which hemostasis was achieved.It was reported that the patient lost 2883ml of blood prior to device deployment; the patient lost 973ml after device malfunction (total estimated blood loss of 3856ml).The patient received a 4 unit blood transfusion.

Manufacturer Narrative

Event description: it was reported that a bakri tamponade balloon catheter could not be deflated during use.The user placed the device transvaginally for treatment of postpartum hemorrhage.The balloon was placed and inflated by injecting 100ml of distilled water.The user then attempted to remove the water to deflate the balloon in order to reposition the device; but the water could not be removed.The user then pulled the device out with the balloon still inflated and replaced it with another balloon catheter with which hemostasis was achieved.It was reported that the patient lost 2883ml of blood prior to device deployment; the patient lost 973ml after device malfunction (total estimated blood loss of 3856ml).The patient received a 4 unit blood transfusion.Investigation ¿ evaluation a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, and quality control data.One bakri tamponade balloon catheter was returned for investigation.The device was returned filled with fluid, attached to a fluid-filled syringe.There was no stopcock attached.The syringe was removed, and fluid began to flow from balloon without assistance.The syringe was used to fully deflate balloon with no resistance.The balloon was successfully deflated, and the reported failure mode could not be recreated.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists 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 instructions for use (ifu), 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." the complaint was not confirmed, as the device functioned as intended.Evaluation of the returned device could not re-create the failure mode.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Event Description

Upon further review of this event by a clinical reviewer and management, it has been determined that this complaint is non-reportable.It has been determined that the device failure mode of ¿failure to deflate¿ did not cause or contribute to the patient's excessive blood loss or requirement for a blood transfusion.No previous serious injuries have been reported due to the device failure mode of ¿failure to deflate¿.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction: b5 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.

• 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: 15459065
• MDR Text Key: 300300346
• Report Number: 1820334-2022-01510
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)240818(10)14159273
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 14159273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• 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 Outcome(s): Required Intervention
• Patient Sex: Female