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 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: agent.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 after a cesarean section (cs) delivery at 39+4weeks gestation, the incision was sutured and a bakri tamponade balloon catheter was placed transvaginally to treat (pph) post- partum hemorrhage caused by uterine inertia.Saline was injected, when the volume injected reached 50ml, blood amount from the drainage catheter was noted increasing.The bakri was immediately removed and tested in-vitro.The liquid which was supposed to flow into the balloon actually flowed out by the drainage catheter.Another bakri was utilized and hemostasis was achieved.The total volume of blood loss was 800ml.The patient did not experience any adverse effects as a result of this alleged product malfunction.

Event Description

Additional information was received 01jul2019: the patient lost an estimated 600ml of blood prior to bakri placement.The bakri was placed by hand, no tools were used.This was a singleton gestation and the patient had no history of full thickness hysterotomy.

Manufacturer Narrative

Additional information: 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 the instructions for use (ifu).The complainant returned one open package containing a bakri postpartum balloon for investigation.Visual examination confirmed no visible damage on the catheter.A function test was performed by inflating the balloon with 100ml of tap water.No leak detected around the balloon area.A leak was observed from the distal sideport.Communication between catheter lumens caused a leak in the catheter.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.The 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 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.Cause of lumen communication was not determined.Conclusion: 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: 8741603
• MDR Text Key: 150028946
• Report Number: 1820334-2019-01539
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)201011(10)8283422
• 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: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2020
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 8283422
• 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: 36 YR
• Patient Weight: 66