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

Model Number G30673

Device Problems Deflation Problem (1149); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

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 reported during arrest of hemorrhage using the bakri tamponade balloon catheter, water drained from the balloon because the three-way stopcock was loosened while the patient was being moved to a hospital ward after device placement, which resulted in deflation of the balloon.The user continued to use the complaint device with the tube crimped after replacing the three-way stopcock with another manufacturer's one and refilling the balloon with water.There have been no adverse effects to the patient reported.The user(s) did not verify if the lock was firmly tightened prior to use.When the user touched the lock when leakage occurred, he/she felt that the lock was loose.Threads of the female and male locks could be engaged properly when these were tightened.Additional information regarding the patient and event have been requested.At the time of this report, no further information is available.According to the instructions for use (ifu) that accompanies this device: precautions: this product is intended for use by physicians trained and experienced in obstetrics and gynecological techniques.Instructions for use: note: remove the stopcock to aid in placement and reattach prior to filling balloon.Note: ensure that all product components are intact and the hysterotomy is securely sutured prior to inflating the balloon.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: concomitant medical products.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, instructions for use, quality control data, and trends.The complainant returned one device for investigation.The device was returned filled with blood.The stopcock returned in the off position.Functional testing determined there are no leaks in the balloon or stopcock.With stopcock in the off position, the device does not leak.With stopcock in the open position, the device drains.A review of the device history record revealed there are no related non-conformances associated with the complaint device lot.No other lot related complaints that have been received.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: warnings this device intended as a temporary means of establishing hemostasis in cases indicating conservative management of postpartum uterine bleeding.The bakri postpartum balloon is indicated for use in the event of primary postpartum hemorrhage within 24 hours of delivery.The device should not be left indwelling for more than 24 hours.Patients in whom this device is being used should be closely monitored for signs of worsening bleeding and/or disseminated intravascular coagulation (dic).In such cases, emergency intervention per hospital protocol should be followed.Patient monitoring is an integral part of managing postpartum hemorrhage.Signs of deteriorated or non-improving condition should lead to a more aggressive treatment and management of patient uterine bleeding.To conclude, functional testing showed the device functions fine, no leaks were noted in the balloon or the stopcock.The stopcock was found to function properly.The customer¿s difficulty could not be recreated during the investigation.It is possible, the stopcock was not in the correct position during use.The complaint could not be confirmed.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.

Event Description

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

• 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: 8400845
• MDR Text Key: 138427897
• Report Number: 1820334-2019-00591
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)210319(10)8672873
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2021
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 8672873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1