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

Model Number G24237

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

Name and address: phone: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during treatment of a post-partum hemorrhage, a cook bakri postpartum balloon with rapid instillation components leaked.The patient experienced 800ml of blood loss prior to use of the device.The operator inserted the device in position with the help of sponge forceps.400ml saline was then injected into the balloon.After the hemorrhage was observed unimproved under ultrasound, the device was removed and a pinhole leak was noted to the device.The patient lost 300ml of blood after the placement of the device.The procedure was successfully completed with another device without any adverse effects reported to the patient.

Manufacturer Narrative

Event summary: cook was informed of an incident involving a cook bakri postpartum balloon with rapid installation components.As reported, the complaint device was used to treat postpartum hemorrhage.The patient experienced about 800ml of blood loss prior to use.The operator inserted the device in position with the help of sponge forceps.400ml of saline was injected into the balloon, and the operator observed the situation didn't improve under ultrasound b.The operator removed the device by hand and checked in vitro.Leaking was found on the balloon.The procedure was completed by using another new device.300ml of blood was lost after the reported difficulty.No adverse effects were reported.Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, specifications, and quality control data.Visual examination confirmed the device was returned in used condition.A functional test was performed on the open device by inflating the balloon with tap water.A leak was confirmed in the balloon material.Under magnification, a puncture mark was observed on the balloon material.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu) provided with the device warns,"the maximum inflation is 500ml.Do not overinflate the balloon.Balloon should be inflated with sterile liquid." the ifu also cautions to avoid excessive force when inserting the balloon into the uterus.The puncture marks on the returned balloon were likely caused by sponge forceps during placement of the device.Based on the available information, cook has concluded that he most probable cause of the reported event was unintended user error.Cook will continue to monitor this device via the complaints database for similar complaints.Per the quality engineering risk assessment, no further action is required.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

No new patient or event information has been received since the last report was submitted.

• 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: 10484828
• MDR Text Key: 207318391
• Report Number: 1820334-2020-01617
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)210608(10)8938758
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2021
• Device Model Number: G24237
• Device Catalogue Number: J-SOSR-100500
• Device Lot Number: 8938758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 68