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

Catalog Number J-SOSR-100500

Device Problem Off-Label Use (1494)

Patient Problems Abdominal Pain (1685); Uterine Perforation (2121); Blood Loss (2597)

Event Date 07/21/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: bakri placement reportedly required weighted speculum, single tooth tenaculum, uterine sound, hegar dilators, and kling gauze for vaginal packing.Procedure performed under general anesthesia.Pma/510k # k170622.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported the bakri postpartum balloon with rapid instillation components was utilized on a patient with endometrioid cancer for treatment of acute blood loss and anemia secondary to uterine hemorrhage/ bleeding.The insertion and inflation of the device was reported to have ¿caused a perforation of the uterus¿.Further event details were obtained.The patient was first evaluated in the emergency department (ed) on (b)(6) 2018 at 0200 hours.The patient with a known history of grade 3 endometrioid adenocarcinoma and on admission was found to be anemic with a 2 week history of vaginal bleeding and recent episode of syncope.At 0243 hours hemoglobin / hematocrit (h/h) levels were 7/21.7 respectively.The patient was then transfused 4 units packed red blood cells (prbc).A complete blood count (cbc) was performed at 0900 hours and showed h/h 12.7/37 respectively.A decision was made to proceed to the operating room (or) for placement of a bakri postpartum balloon in an attempt to control persistent vaginal bleeding.The bakri postpartum balloon was placed at approximately 1000 hours.At that time, there was no reported suspicion for rupture after the procedure.The patient was transferred to the intensive care unit (icu) and was reported to have the bleeding controlled and remained intubated.The estimated blood loss from the bakri postpartum balloon placement was 300cc.The patient was then transferred to another facility.The patient was evaluated around 1500 hours on (b)(6) 2018.On evaluation, the patient had been extubated and was receiving fentanyl/oxycodone for pain control and reported significant abdominal/pelvic pain and refused vaginal exam.A repeat abdominal (abd) and pelvic computed tomography (ct) scan were performed at 1600 hours and found that the bakri postpartum balloon was in the left upper abdomen as a result of uterine rupture.Immediately after the ct, the resident spoke with the attending regarding the findings.The bakri postpartum balloon was deflated, patient bloused fentanyl, and multiple attempts made to remove the device.The removal was unsuccessful at that time due to patient intolerance.The patient was reported to be "relatively stable", and the decision was made to leave the bakri postpartum balloon in place.The patient was medically managed until surgery on (b)(6) 2018 at which time the bakri postpartum balloon was removed and uterine rupture repaired.The patient was reported to have required ¿exam under anesthesia to remove bakri, cystoscopy, exploratory laparotomy, radical abdominal hysterectomy, bilateral salpingo-oophorectomy, right pelvic lymph node dissection¿.

Manufacturer Narrative

Investigation evaluation: the complaint device was not returned for an evaluation as the facility reports it was discarded and no photographs or imaging was provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of the instructions for use, quality control data, and trends.A review of relevant manufacturing documents was conducted.The device is inspected visually and functionally by the supplier for leaks, inflation, and deflation of the device.Since the lot number was unknown, the device history record could not be reviewed and a search for additional complaints related to this lot could not be performed.The instructions for use (ifu) provides the proper warnings, precautions, and instructions for use.As found in the ifu: intended use: this device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.Warnings: this device is intended as a temporary means of establishing hemostasis in cases indicating conservative management of postpartum uterine bleeding.The bakri postpartum balloon is indicated for use in the event of primary postpartum hemorrhage within 24 hours of delivery.The event is likely related to the off-label use of the device.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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

There has been no new information received since the last report was submitted.

• 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
• MDR Report Key: 7827118
• MDR Text Key: 118576248
• Report Number: 1820334-2018-02407
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 64