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

Model Number G24237

Device Problem Positioning Failure (1158)

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

Event Date 10/14/2022

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 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 a cook bakri postpartum balloon with rapid instillation components' prolapsed.The patient had a pre-existing condition of placenta previa and underwent a cesarean section delivery.At the end of the procedure, it was noted that the patient lost 700ml of blood, so the device was deployed and placed transabdominally.No metal tools were used to place the device.The uterine incision was sutured, then the balloon was filled with 50ml saline and gauze was being placed in the posterior fornix when it was noted that the balloon had slipped out of the patients uterine cavity.The patient then lost an additional 50-100ml of blood; total blood loss was less than 800ml.A new device was placed, hemostasis was achieved, and no adverse effects were reported.

Manufacturer Narrative

Event description: it was reported a cook bakri postpartum balloon with rapid instillation components' prolapsed.The patient had a pre-existing condition of placenta previa and underwent a cesarean section delivery.At the end of the procedure, it was noted that the patient lost 700ml of blood, so the device was deployed and placed transabdominally.No metal tools were used to place the device.The uterine incision was sutured, then the balloon was filled with 50ml saline and gauze was being placed in the posterior fornix when it was noted that the balloon had slipped out of the patients uterine cavity.The patient then lost an additional 50-100ml of blood; total blood loss was less than 800ml.A new device was placed, hemostasis was achieved, and no adverse effects were reported.Investigation evaluation reviews of the documentation, including the complaint history, device history record (dhr), instructions for use (ifu) and quality control procedures, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.The complaint device was returned for evaluation.Visual and functional testing were unable to confirm any defects with the device.Additionally, 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 records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no nonconforming product from this lot exists in house or in the field.Cook also reviewed product labeling.The product ifu for bakri postpartum balloon provides the following information to the user related to the reported failure mode: transabdominal placement, post-cesarean section "1.Determine uterine volume by direct examination." "2.From above, via access of the cesarean incision, pass the tamponade balloon, inflation port first, through the uterus and cervix." "note: remove and stopcock to aid in placement and reattach prior to filling balloon." "3.Have an assistant pull the shaft of the balloon through the vaginal canal until the deflated balloon base comes into contact with the internal cervical ostium." "4.Close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing." "note: ensure that all product components are intact and the hysterotomy is securely sutured prior to inflating the balloon.If clinically relevant, the abdomen may remain open upon inflation of the balloon to closely monitor uterine distention and confirm the hysterotomy close." "note: if clinically relevant, a b-lynch compression suture may be used in conjunction with the bakri postpartum balloon." how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." the information provided upon review of the product labeling review, device master record, and device history record, gave evidence that the device was manufactured to specification.Cook has concluded that a failure by the user to follow instructions likely contributed to this event.The appropriate personnel have been notified and we 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: 15758730
• MDR Text Key: 307512462
• Report Number: 1820334-2022-01713
• Device Sequence Number: 1
• Product Code: OQY
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2024
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 13731953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• 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 Age: 29 YR
• Patient Sex: Female
• Patient Weight: 68 KG