MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; OQY INTRAUTERINE BALLOON

Model Number G30673

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510k #: k170622.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 at 10:00 am after a cesarean section (cs) delivery, a bakri tamponade balloon catheter was placed through the cs incision to treat post-partum hemorrhage.The balloon was inflated with 400 ml of saline.In the afternoon the doctor found the position of balloon had descended, and the sheet beneath the patient was wet.The doctor checked the device and found saline leaking slowly from the joint of tubing.Upon finding the leakage, another 400 ml saline was injected to make sure adequate compression was provided.The next day, the patient recovered well.The patient did not experience any adverse effects as a result of this alleged product malfunction.

Manufacturer Narrative

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, the device history record, quality control data, and review of ifu.The complainant returned one open package containing a bakri postpartum balloon for investigation.Reported lot number confirmed.Visual examination confirmed balloon was received with the stopcock attached to the inflation line on the proximal end of the catheter.No visible damage observed on the catheter.A leak test was performed by injecting 80 ml of water into the balloon.No leaks were observed in the balloon material.Pressure applied to the balloon did not reveal leakage from the balloon or from the proximal end connection.This catheter functioned as intended.When the stopcock was loose and/or the valve in a half-closed position a leak was created.Device history record (dhr) review for this lot shows no related non-conformances.A review of complaint history revealed no other complaints associated with the complaint device lot number.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Cook also reviewed product labeling.The product ifu for this device provides the following information to the user related to the reported failure mode: precautions "avoid excessive force when inserting the balloon into the uterus." how supplied: "upon removal from the package, inspect the product to ensure no damage has occurred." the ifu also warns the maximum inflation is 500ml.Do not overinflate the balloon.Balloon should be inflated with sterile liquid.Balloon should never be inflated with air, carbon dioxide or any gas, and precautions to avoid excessive force when inserting the balloon into the uterus.Illustrations for proper stopcock placement and function are listed in the ifu.The most probable cause improper use or placement of the stopcock.Conclusion: cook has concluded unintended use error contributed to this incident per the quality engineering risk assessment, no further action is warranted.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 01jul2019: the bakri balloon was placed in the process of the delivery.The post partum hemorrhage was due to uterine atony.The patient lost an estimated (estimated by space) 400ml of blood prior to bakri placement, and had no blood loss after bakri placement.The balloon was inflated after the hysterotomy was closed.There were no additional interventions required.The device was not handled by or in the proximity of any metal tools that might have damaged the balloon.This was a singleton gestation, and the patient had no comorbidities, no previous coagulation disorders, and no prior full thickness hysterotomy.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8722594
• MDR Text Key: 148792511
• Report Number: 1820334-2019-01494
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)211001(10)9201024
• Combination Product (y/n): N
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9201024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 55