MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; OQY INTRAUTERINE BALLOON

Catalog Number J-SOS-100500

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k170622.(b)(4).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 initially reported after cesarean section, the patient suffered postpartum hemorrhage due to uterine atony.And the patient was given oxytocin injection to hemostasis but failed.The amount of bleeding reached 800 ml before placing this device.So, bakri balloon was used to stop bleeding.The physician placed the balloon into the uterine cavity through vagina.After injected 430 ml saline (50ml/each time), the balloon had ruptured in a longitudinal direction.The physician changed to another same type of device to use and the stop bleeding successfully.Additional information was received on 21sep2018.It was reported that total blood loss was 800ml and that the patient did not receive blood products.There were no adverse effects experienced by the patient.

Event Description

There has been no new information received since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, drawings, instructions for use, and quality control data.One bakri tamponade balloon catheter was returned for investigation.A visual examination notes there is a split in the balloon material starting 5 mm from the distal end and it extends 6 cm.A review of the device history record found there were no non-conformances related to the reported failure.A review of complaint history records revealed one other similar complaint for balloon rupture associated with the complaint device lot number 7837260.The investigation for the similar complaint determined the balloon damage/rupture was attributed to the use of metal tools when placing the balloon.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The cause of the split in the balloon material could not be determined in this instance.Measures have been initiated to address this failure mode.Cook medical has notified the appropriate personnel and 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: 7922282
• MDR Text Key: 122645761
• Report Number: 1820334-2018-02878
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)200417(10)7837260
• 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: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2020
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 7837260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 10/24/2018
• Supplement Dates FDA Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 76