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 Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # - 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 during the procedure they examined the cook bakri balloon was burst so they changed the balloon.According to the report, no unintended part of the device remained inside the patient.There were no additional procedures required and there we no adverse effect to the patient due to this occurrence.Despite attempts to obtain additional patient and event details there has been no additional information provided at the time of this report.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, instructions for use, and specifications.One cook bakri postpartum balloon with rapid instillation components was returned for investigation.Initially the burst bakri balloon was reported with an unknown lot number.Lot number 8491019 was found on the returned bakri balloon associated with this complaint.A leak test was performed and determined the balloon is leaking from two holes on opposite sides of the balloon material.Visual examination notes forceps marks on the balloon material near the holes where the leaks occurred.The device history record was reviewed and no non-conformances were identified that would be related to the reported failure.A complaint history search revealed this is the only complaint associated with lot number 8491019.The instructions for use (ifu) states precaution: avoid excessive force when inserting the balloon into the uterus.It is possible that the use of forceps on the balloon material caused the bakri balloon to leak.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The cause for this specific failure is traced to the user; failure to follow instructions.The risk analysis for the rupture or leakage of the balloon was reviewed.Measures have been initiated to address this failure mode.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

Event Description

Additional information received on 26oct2018.Patient was at 38 weeks gestation.Patient delivered via c-section; this was her second pregnancy (gravida: 2).After the c-section the bleeding did not stop, thus necessitating use of the bakri balloon.Forceps were used in the placement of the balloon.Blood loss prior to balloon placement was approximately 1liter, with a total of 3 liters lost.The patient did receive blood/blood products.The patient stayed in the hospital 2 extra days.Additional information received 05nov2018: the patient had a previous cesarean section delivery prior to this delivery.The patient has no uterine anomalies.It was confirmed that forceps were used for balloon placement through the incision.The blue port was used to fill the balloon.Another bakri balloon was used to achieve hemostasis.

• 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: 7923574
• MDR Text Key: 122645926
• Report Number: 1820334-2018-02834
• 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: distributor,other,user facili
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2021
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 8491019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Date Manufacturer Received: 10/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 90