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

Catalog Number J-SOSR-100500

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: k170622.(b)(6).A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported, during an unspecified procedure using a cook bakri postpartum balloon with rapid instillation components, that the blue stop cock fell off the device.Following severe post partum hemorrhage, the bakri balloon was placed in the uterus.The stopcock was not able to be tightened correctly and the sterile water used to inflate the balloon spilled out.The balloon then fell out of the patient, and the stop cock fell off the rest of the device.No unintended section of the device remained inside the patient.It is unknown how the procedure was completed after this difficulty.No known adverse events have been reported as a result of the alleged malfunction.Additional details have been requested regarding the patient and event.At this time no additional information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation evaluation: reviews of the instructions for use and quality control data were conducted during the investigation.The device was not returned for evaluation.Since the lot number was unknown, the device history record could not be reviewed and it is unknown if any nonconformances are related to this lot.A search for additional complaints related to this lot also could not be performed.The instructions for use (ifu) included with this device provides the following information to the user related to the reported failure mode: instructions: transabdominal placement, post-cesarean section 1.Determine uterine volume by direct examination.2.From above, via access of the cesarean incision, pass the tamponade balloon, inflation port first, through the uterus and cervix.Note: remove and stopcock to aid in placement and reattach prior to filling balloon.A review of relevant manufacturing documents was conducted.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The device is inspected visually and functionally by the supplier for leaks, inflation, and deflation of the device.The complaint was confirmed based on customer testimony.A definitive cause of the incident could not be determined from the available information.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue our monitoring of similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information received on (b)(6) 2019: after a vaginal delivery, the patient lost 3.5 liters of blood within the 35 minutes prior to balloon placement.Manual abruption was performed on the placenta and the bleeding stopped.The bakri balloon was then placed and there was no bleeding still.After placement there was "little bleeding".After about 3 hours the balloon fell out because the stop cock detached causing the balloon to deflate.There was a minimal amount of bleeding that had occurred, but another bakri balloon was placed to ensure that bleeding was finished.Placing the second bakri balloon was reported to be uncomfortable for the patient.

• 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: 8974261
• MDR Text Key: 156924820
• Report Number: 1820334-2019-02253
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1