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 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

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 during treatment of post partum hemorrhage (pph) using a bakri tamponade balloon catheter, the balloon leaked.The patient lost 1200 ml of blood prior to bakri balloon placement.The bakri was placed using a vaginal speculum and sponge forceps and inflated with an unspecified volume of saline.After placement of the bakri balloon, the operator found a leakage in the balloon and replaced it with a similar device to complete the procedure.The patient lost an additional 300ml of blood for a total volume of blood loss of 1500ml.Hemostasis was achieved with the placement of the second device.The patient was given no blood products.No additional consequences to the patient have been reported as a result of this occurrence.

Event Description

There is no new patient or event information to report.

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, review of ifu, manufacturing instructions, and trends.The complainant returned one open package containing a bakri postpartum balloon for investigation.Reported lot number confirmed.A visual examination confirmed the device was returned in used condition.A functional test was performed by inflating the balloon with 150ml of tap water.A leak was confirmed in balloon material.Under magnification the leak originated from the seam in the balloon material.Device history record (dhr) review for this lot shows no 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.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.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: 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.The ifu also precautions to avoid excessive force when inserting the balloon into the uterus.Most probable cause, damaged during use.Conclusion: cook has concluded a definitive conclusion could not be determined.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.

• 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: 8698313
• MDR Text Key: 148037464
• Report Number: 1820334-2019-01365
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)210115(10)8508679
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 8508679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR