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 05/26/2023

Event Type  Injury  

Event Description

As reported, during treatment of a postpartum hemorrhage (pph) due to uterine atony, a 'cook bakri postpartum balloon with rapid instillation components' device was used but would not stay in place.The user removed the placenta then placed the balloon in the patient and injected 500ml of saline into the device, the balloon then slipped/migrated down during use.The patient lost ~600ml of blood prior to device difficulty and an additional ~300ml after the difficulty; total estimated blood loss (ebl) was ~900ml.It was reported that the device remained indwelling for ~24 hours.Procedure was completed using another balloon.The device was not handled by or in the proximity of any metal tools that may have damaged the balloon.The patient was transfused with one (1) unit of blood.A section of the device did not remain inside the patient¿s body.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address = phone: (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

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, unavailable, or unchanged.Event summary as reported, during treatment of a postpartum hemorrhage (pph) due to uterine atony, a 'cook bakri postpartum balloon with rapid instillation components' device was used but would not stay in place.The user removed the placenta then placed the balloon in the patient and injected 500ml of saline into the device, the balloon then slipped/migrated down during use.The patient lost ~600ml of blood prior to device difficulty and an additional ~300ml after the difficulty; total estimated blood loss (ebl) was ~900ml.It was reported that the device remained indwelling for ~24 hours.Procedure was completed using another balloon.The device was not handled by or in the proximity of any metal tools that may have damaged the balloon.The patient was transfused with one (1) unit of blood.A section of the device did not remain inside the patient¿s body.The patient 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 were conducted.The complaint device was not returned; therefore, no physical examinations could be performed.A document-based investigation evaluation was performed.Review of the dhr for lot 14503318 revealed there were no nonconformances.A database search identified one other event reported for the same failure mode and was reported by the same customer facility.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.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed product labeling.The product ifuprovides the following information to the user related to the reported failure mode."the maximum inflation is 500 ml.Do not overinflate the balloon.Overinflation of the balloon may result in the balloon being displaced into the vagina.¿ precautions ¿ avoid excessive force when inserting the balloon into the uterus ¿ instructions for use important: prior to transvaginal or transabdominal placement of the bakri postpartum balloon, the uterus should be free of all placental fragments, and the patient should be evaluated to ensure that there are no lacerations or trauma to the genital tract and that the source of the bleeding is not arterial.Transvaginal placement 1.Determine uterine volume by direct examination or ultrasound examination.2.Insert the balloon portion of the catheter into the uterus, making certain that the entire balloon is inserted past the cervical canal and internal ostium.3.Place an indwelling urinary bladder foley catheter at this time, if not already in place, to collect and monitor urine output.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 the 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 closure.Note: if clinically relevant, a b-lynch compression suture may be used in conjunction with the bakri postpartum balloon.Balloon inflation with syringe warning: always inflate the balloon with sterile liquid.Never inflate with air, carbon dioxide or any other gas.Warning: the maximum inflation is 500 ml do not overinflate the balloon.Overinflation of the balloon may result in the balloon being displaced into the vagina.Note: to ensure that the balloon is filled to the desired volume, it is recommended that the predetermined volume of fluid be placed in a separate container, rather than relying on a syringe count to verify the amount of fluid that has been instilled into the balloon.1.Place an indwelling urinary bladder foley catheter at this time, if not already in place, to collect and monitor urine output.2.Using the enclosed syringe, begin filling the balloon to the predetermined volume through the stopcock.3.Once the balloon has been inflated to the predetermined volume, confirm placement via ultrasound.Note: see fig.1 for proper placement.4.If desired, traction can be applied to the balloon shaft.In order to maintain tension, secure the balloon shaft to the patient's leg or attach to a weight, not to exceed 500 grams.Note: to prevent displacement of the balloon into the vagina, counterpressure can be applied by packing the vaginal canal with iodine- or antibiotic-soaked vaginal gauze.5.Connect the drainage port to a fluid collection bag to monitor hemostasis.Note: to adequately monitor hemostasis, the balloon drainage port and tubing may be flushed clear of clots with sterile isotonic saline.6.Monitor the patient continuously for signs of increased bleeding and uterine cramping.Balloon inflation with rapid instillation components see figs.2-8, at the front of this booklet.Note: ultrasound should be used to confirm proper placement of the balloon once the balloon is inflated to the predetermined volume.Balloon removal note: the timing of 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.1.Remove tension from the balloon shaft.2.Remove any vaginal packing.3.Using an appropriate syringe, aspirate the contents of the balloon until fully 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 to facilitate more rapid deflation.4.Gently retract the balloon from the uterus and vaginal canal and discard.5.Monitor patient for signs of bleeding.Based on the available information, cook concluded a definitive conclusion 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.

• 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: 17075573
• MDR Text Key: 316750943
• Report Number: 1820334-2023-00695
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)250128(10)14503318
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 14503318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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
• Treatment: SYRINGE, STERILE WATER/SALINE.
• Patient Outcome(s): Other
• Patient Sex: Female