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 11/21/2019

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 was reported that after a vaginal delivery the patient experienced postpartum bleeding."routine" hemostatic drugs were initially utilized in an attempt to stop the bleeding, but they were not effective; resulting in the loss of about 1000 ml of blood.The operator then placed a bakri tamponade balloon catheter with sponge forceps and then inflated the balloon.No leaking was noted at this time.20 minutes after placing the bakri, blood began to flow out.An ultrasound was used to examine the situation and found that the balloon was getting smaller.The operator then removed the bakri and found a leak through a pinhole.Hemostasis was achieved by placing a second bakri tamponade balloon catheter.80 ml of blood was lost after the second bakri was placed.It was reported the patient did not experience any adverse effects due to this incident.

Event Description

No additional patient or event information has been received.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Ec method code desc - 5: communication/interviews (4111).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.One device was returned for investigation.A visual examination confirmed the catheter was returned in used condition.A functional test was performed on the device by inflating it with 150ml of tap water.A leak was confirmed in the balloon material.Under magnification, a horizontal cut was visible on the balloon material.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: 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.The ifu also precautions to avoid excessive force when inserting the balloon into the uterus.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded unintended user error contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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: 9418448
• MDR Text Key: 195076576
• Report Number: 1820334-2019-03020
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)211116(10)9316362
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2021
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9316362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 59