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 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: customer service.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 an unspecified procedure following a cesarean section delivery using a bakri tamponade balloon catheter, the balloon leaked.A second balloon was used to complete the procedure.There were no adverse effects to the patient, and the patient did not require any additional procedures 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.

Manufacturer Narrative

The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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 on 10jul2020: the leak was present from the balloon material.There was a blood loss of 500ml noted.Hemostasis was successfully achieved by using the second balloon.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: it is reported during an unspecified procedure following a cesarean section delivery using a bakri tamponade balloon catheter, the balloon leaked from the balloon material.There was a blood loss of 500ml noted.Hemostasis was successfully achieved by using the second balloon.A second balloon was used to complete the procedure.There were no adverse effects to the patient, and the patient did not require any additional procedures as a result of this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.One open package containing a bakri postpartum balloon catheter was returned for investigation.Visual examination confirmed the catheter was returned in used condition.The stopcock was attached to the inflation line.A functional test was performed on the open device by inflating the balloon with tap water.A leak was confirmed near the middle of the balloon material.Under magnification several marks in the balloon material were observed, and one mark punctured the material, causing balloon to leak.The balloon appeared damaged by an instrument of undetermined origin.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this product lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device specifications or quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use, which warn, ¿the maximum inflation is 500ml.Do not overinflate the balloon.Overinflation of the balloon may result in the balloon being displaced into the vagina.¿ the ifu also precautions to avoid excessive force when inserting the balloon into the uterus.Based on the available information, cook has concluded that unintended use error contributed to this incident, as the device appeared damaged by an unknown instrument.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 10256968
• MDR Text Key: 198324099
• Report Number: 1820334-2020-01283
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)220418(10)9678700
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2022
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9678700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 70