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 Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2020

Event Type  malfunction  

Manufacturer Narrative

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 prior to an unspecified procedure using a bakri tamponade balloon catheter, the physician tested the balloon and found it to be leaking.A new balloon as used to achieve hemostasis.No adverse effects to the patient have been reported as a result of this occurrence.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported, the operator tested the balloon prior to use and found it was leaking from the balloon material.Hemostasis was successfully achieved using a new device.No adverse effects were reported.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, specifications, instructions for use, and quality control data.One bakri postpartum balloon catheter was returned for investigation in a prior to use condition.The stopcock was attached to the inflation line.Blood was observed on the catheter.A function test was performed by flushing water through the catheter to inflate the balloon.A leak was confirmed from the distal end of the balloon material.Under magnification, the balloon displayed an irregular-shaped cut mark located near the distal end of 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 were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that 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 relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported 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) provided with this device state, "upon removal from the package, inspect the product to ensure no damage has occurred." based on the information available, investigation has concluded that the balloon was likely punctured by an instrument of undetermined origin.Cook could not determine a definitive cause of this event from the available information.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.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.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 provided 14jul2020: the patient lost 770 ml of blood prior to balloon placement.The patient lost an additional 80 ml of blood after the alleged product malfunction (850ml total blood loss).The balloon was found to be leaking at the upper part of the balloon material.

• 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: 10269932
• MDR Text Key: 198731132
• Report Number: 1820334-2020-01297
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)211025(10)9262016
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2021
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9262016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR