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

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Pma/510k # : k170622.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.[(b)(4)].

Event Description

In the journal article "which uterine sparing technique should be used for uterine atony during cesarean section? the bakri balloon or the b-lynch suture?" published in the archives of gynecology and obstetrics (2016) 294:511-17, it is reported in four women the bakri failed and internal iliac artery ligation (iial) was required.Prior to bakri placement, all women were given oxytocin [40 iu in 500ml of normal saline at the rate of 125ml/h (166mu/min) intravenously].In the cases where uterine atony was unresponsive to the standard oxytocin regimen, uterine massage and bimanual massage; the patients were given ergometrine (intramuscularly 0.25-0.5mg), and misoprostol (0.8-1mg rectally).In the case of failure of the uterotonic treatment, uterine sparing techniques were used (bakri balloon or b-lynch sutures).In four women, the bakri balloon was used and "failed".No details were provided regarding how the bakri failed.In these four women, iial was performed.After iial, in three women the bleeding halted (this report).In one woman, bleeding did not stop, and a hysterectomy was performed (reported in patient identifier (b)(6)).No other consequences to the patients have been reported as occurring.Additional details regarding the patients and events have been requested.At this time, no additional information has been provided.

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 by the authoring physician: this case involves 25-years-old woman in 38 weeks of gestation underwent a elective cesarean section due to placenta previa totalis and transvers lie.Obstetric bleeding due to uterine atony (not placenta previa) during cesarean section was initially managed with bakri balloon via inflation of 360 ml saline in the corpus of the uterus however, bleeding did not stop and ligation of bilateral internal iliac arteries (iial) performed.Following iial, bleeding was controlled , she received 2 units of packed red blood cells and estimated blood loss was 2000 ml.(this case underwent re-laparotomy in the 1st postoperative day due to intra-abdominal bleeding from the infundibulopelvic ligament).Clarification provided by the authoring physician and in the additional journal article provided defines bakri failure as bleeding did not stop within 15 minutes of inflation with occupation of the whole uterine cavity.There was no leakage or rupture of the balloon.Additional details provided by authoring physician regarding the other two women originally reported with bakri "failure" requiring iial, these cases are reported in patient identifier (b)(6) and patient identifier (b)(6).

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation - evaluation.Reviews of the instructions for use (ifu) and quality control data were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of complaint history could not be completed due to lack of information from the user facility.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." "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." instructions for use "important: prior to transvaginal or transabdominal placement of the bakri postpartum balloon, the uterus should be free of all placental fragments, and the patient should be evaluated to ensure that there are no lacerations or trauma to the genital tract and that the source of the bleeding is not arterial." cook has concluded that the cause of the event cannot be traced to the complaint device and was most likely related to inadvertent damage to the infundibulopelvic (ovarian) ligament during surgery and uterine atony.There was no malfunction of the device.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: 8892218
• MDR Text Key: 154239132
• Report Number: 1820334-2019-02009
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR