MAUDE Adverse Event Report: COOK, INC. COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC

Model Number N/A

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

Patient Problems Necrosis (1971); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure, additional (2564)

Event Type  Injury  

Event Description

According to the initial reporter, the event occurred approximately two months ago.A bakri balloon was placed for a postpartum hemorrhage.After being in place for 12 hours, necrosis was found.The pt had to have a hysterectomy performed.This pt had a bicornuate uterus prior to the placement of the device.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

Evaluation: a review of the complaint history, instructions for use (ifu), quality control and trends was conducted during the investigation.Additionally, interview with personnel were conducted.The device is shipped with an ifu that describes the intended use, specific items are addressed such as: the ifu states the contraindication of "untreated uterine anomaly" thus indicating that this patient with a bicornuate uterus was contraindicated for this device."the maximum inflation is 500 ml.Do not overinflate the balloon.Over-inflation of the balloon may result in the balloon being displaced into the vagina." "patient monitoring is an integral part of managing postpartum hemorrhage.Signs of deteriorating or non-improving condition should lead to a more aggressive treatment and management of patient uterine bleeding." this patient had a uterus that was in the shape of a heart prior to the placement of the device." it is assumed that the user is referring to a bicornuate uterus.The device was contraindicated for this patient.The device was not designed to accommodate the shape of this patients uterus.Thus using this device could have caused excess pressure on the patients tissue leading to necrosis.Additionally, depending on the degree of the cleft or septation between the two uterine horns, this cleft could push against the bakri device resulting in excess pressure on the patients tissue leading to necrosis.While no images were provided, it is highly likely that the patient anatomy contributed to the necrosis as their condition was contraindicated for the use of this device.This ultimately led to the patient needing a hysterectomy.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Based on the information provided and the investigation the cause of this issue was most likely the patient condition and the end user not following label copy instructions.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the health risk assessment, no further action is required.

Event Description

According to the initial reporter, the event occurred approximately two months ago.A bakri balloon was placed for a postpartum hemorrhage.After being in place for 12 hours, necrosis was found.The patient had to have a hysterectomy performed.This patient had a bicornuate uterus prior to the placement of the device.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4853567
• MDR Text Key: 16182685
• Report Number: 1820334-2015-00357
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/21/2015
• 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 Outcome(s): Other; Required Intervention