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

Catalog Number J-SOSR-100500

Device Problem Material Puncture/Hole (1504)

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

Event Date 05/12/2022

Event Type  malfunction  

Event Description

It was reported that cook bakri postpartum balloon with rapid instillation components was punctured and leaked during use.The physician stated the device was difficult to remove possibly due to a suture.The device/balloon was possibly punctured during suturing.The nature of the hemorrhage was in the lower uterine segment, and hemostasis was achieved by balloon tamponade.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Manufacturer Narrative

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

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Corrected summary of event: it was reported that cook bakri postpartum balloon with rapid instillation components was punctured and leaked during use.The device/balloon was possibly punctured during suturing.The nature of the hemorrhage was in the lower uterine segment, and hemostasis was achieved by balloon tamponade.The device was removed and a second balloon was used during the procedure captured under mdr #: 1820334-2022-00953.Investigation evaluation: reviews of the instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.Cook could not complete a review of the device history record or the complaint history due to the lack of lot information from the user facility.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: instructions for use "transabdominal placement, post-cesarean section determine uterine volume by direct examination.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.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.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." "balloon removal note: the timing of the balloon removal should be determined by the attending clinician upon evaluation of the patient once bleeding has been controlled and the patient has been stabilized.The balloon may be removed sooner upon the clinician's determination of hemostasis.The maximum indwell time is 24 hours.Remove tension from the balloon shaft.Remove any vaginal packing.Using an appropriate syringe, aspirate the contents of the balloon until deflated.The fluid may be removed incrementally to allow periodic observation of the patient.Note: in an emergent situation, the catheter shaft may be cut facilitate more rapid deflation.Gently retract the balloon from the uterus and vaginal canal and discard.Monitor patient for signs of bleeding." review of the customer testimony and relevant manufacturing documents does not indicate that the device was manufactured out of specification.Based upon the available information and results of the investigation, cook has concluded that the cause of the puncture was unintended user error.The ifu instructs "avoid puncturing the balloon while suturing." the appropriate personnel have been notified and cook will continue to monitor for similar events.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.

• 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: 14468639
• MDR Text Key: 298203544
• Report Number: 1820334-2022-00954
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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