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

Catalog Number J-SOSR-100500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Occupation: name unknown - head of gynecology department.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 is reported after a uterus cutterage of a patient at (b)(6) gestation, the physician used a cook bakri postpartum balloon with rapid instillation components for post partum hemorrhage management in the abdominal region / uterus.It was provided that a physician of the gynecology team was using the bakri balloon and inflated it up to 300 to 400 milliliters (ml).This volume was estimated by the head of the department when she later joined this case in the or and retrieved the bakri balloon.According to the head of the department's own declaration, she never used a cook bakri postpartum balloon in such a situation, and also would not use a balloon so early into the pregnancy.Moreover, she said that she can imagine that this amount of volume, which to her seemed "unproportionable" (disproportionally) high for a uterus in gestation (b)(6), was one of the potential reasons to cause the subsequent bleeding, which ultimately lead to a hysterectomy for the patient.It was reported that the customer is aware of the contra-indications for the bakri-balloon, such as, cases indicating hysterectomy & pregnancy.She is also aware of the need to determine the uterus volume of by direct examination or ultrasound examination prior to usage of the balloon.No additional consequences to the patient have been reported as occurring.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

The complaint device was not returned, therefore visual examination and functional testing could not be performed.A document based investigation was performed including a review of quality control data, and instructions for use (ifu).Cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.Cook could not complete a search of other complaints associated with the complaint device lot number due to lack of lot information from the user facility.The ifu provides the following information to the user related to the reported failure mode: contraindications "cases indicating hysterectomy" "pregnancy" "a surgical site that would prohibit the device from effectively controlling bleeding" warnings: "this device 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." "patient monitoring is an integral part of managing postpartum hemorrhage.Signs of deteriorated or non-improving condition should lead to a more aggressive treatment and management of patient uterine bleeding." instructions "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." "1.Determine uterine volume by direct examination or ultrasound examination." "note: to ensure that the balloon is filled to the desired volume, it is recommended that the predetermined volume of the fluid be placed in a separate container, rather than relying on a syringe count to verify the amount of fluid that has been installed into the balloon." based on the reported information, the cause of the event could not be traced to the complaint device and was determined to most likely be related to the procedure.The risk analysis for this failure mode was reviewed.Measures are being taken to address this situation.The appropriate internal personnel have been notified and we will continue to monitor 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

Additional information was received on 11jun2019: the bakri performed as expected.There was no device malfunction.However, when the reporting physician appeared at this procedure, the device was already partially dislocated into the vagina due to the volume of fluid it was injected with in relation to the volume of the uterus at 16 weeks gestation.After removal of the balloon-catheter no uterine rupture was assessed, however, the uterus seemed to be atonic to such an extent, that a hysterectomy seemed the only choice to stop the hemorrhage.The reporting physician stated that here was no correlation between the bakri device and the need for the hysterectomy.This patient had a history of post-partum hemorrhage requiring massive transfusion due to atony with her first pregnancy.

• 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: 8678468
• MDR Text Key: 147319316
• Report Number: 1820334-2019-01297
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability