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

Catalog Number J-SOSR-100500

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

Patient Problem Perforation (2001)

Event Date 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

(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 a post cesarean section procedure, the patient delivered her child and proceeded to bleed.The patient was taken to the operating room and had an exploratory laparotomy to see what was causing the excessive bleeding.The physician was not able to find out what was the issue and could not stop the bleeding, so the patient was sent back to the operating room and had a dilation and curettage(dnc) procedure where the bakri balloon of a cook bakri postpartum balloon with rapid instillation components was placed.The patient continued to bleed and was taken to the interventional radiology in which she had a uterine artery embolization.After this procedure, the patient had a computed tomography scan and found that the balloon tip was protruding though the uterus and discovered the perforation.The bakri balloon was removed and the bleeding stopped.The facility was uncertain if the dnc or the bakri balloon had caused the perforation.No unintended portion of the device remained inside the patient¿s body.Additional procedures were required due to this occurrence.No adverse effects or consequences were reported to the patient due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: the complaint device was not returned for evaluation and no photographs or imaging was provided.Without the complaint device, a physical investigation was not able to be completed.A document-based investigation/evaluation was performed.A review of the instructions for use, quality control data, and specifications was conducted.The device lot number has not been provided for the device involved in the complaint.Therefore, a review of the device history records for the complaint device could not be performed.Additionally, a search of the complaints database for additional complaints associated with the complaint device lot number could not be completed.The instructions for use (ifu) contains the following event related instructions: contraindications: arterial bleeding requiring surgical exploration or angiographic embolization.A surgical site that would prohibit the device from effectively controlling bleeding.Precautions: this product is intended for use by physicians trained and experienced in obstetrics and gynecological techniques.Avoid excessive force when the balloon into the uterus.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.A document review identified that the qc inspection procedure for the cook medical device includes an inspection at the 100% level to assure the tip of the device is closed, round and smooth.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A root cause for the perforation could not be determined.Risk analysis for this failure mode was performed, and it was determined that no additional risk mitigating activity is required.This failure mode will continue to be trended.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7194289
• MDR Text Key: 97574042
• Report Number: 1820334-2018-00098
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2018
• 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