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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Type  Injury  

Manufacturer Narrative

Pma/510k #: k170622.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 one case, the bakri balloon was accidently inflated in the lower (uterine) segment instead of the fundus and this led to laceration.Prior to bakri placement, all women in the study 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 one case, during the operation (cesarean) the bakri was accidently inflated in the lower segment of the uterus instead of the fundus.This led to laceration.No product malfunction was reported.It is unknown how the laceration was treated.No other consequences to the patient have been reported as occurring.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection of the complaint device could not be performed as the device was not returned.A document based investigation was performed including a review of instructions for use (ifu), and quality control data.Cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.Cook could not complete a search of other complaints associated with the complaint device lot number due to lack of lot information from the user facility.Cook reviewed product labeling.The product ifu for the device provides the following information to the user related to the reported failure mode: warnings: "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." "bakri postpartum balloon is contraindicated for "a surgical site that would prohibit the device from effectively controlling bleeding".Additionally, the ifu warns, "this device intended as a temporary means of establishing hemostasis in cases indicating conservative management of postpartum uterine bleeding." the ifu instructs, "determine uterine volume by direct examination or ultrasound examination", "insert the balloon portion of the catheter into the uterus, making certain that the entire balloon is inserted past the cervical canal and internal ostium.", "warning: the maximum inflation is 500ml.Do not overinflate the balloon.Overinflation of the balloon may result in the balloon being displaced into the vagina.", and "once the balloon has been inflated to the predetermined volume, confirm placement via ultrasound.", "note: to prevent displacement of the balloon into the vagina.Counterpressure can be applied by packing the vaginal canal with iodine- or antibiotic-soaked vaginal gauze." how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." it is not known if the balloon displacement occurred due to anatomical changes related to scarring of the uterus from previous incisions (2 prior c-section deliveries).It is not known how ¿correct placement¿ was verified when the balloon was initially placed prior to inflation or if the balloon was placed transvaginally or trans-abdominally.It is not known if the inflation volume used was the appropriate volume needed to provide tamponade, but not overinflate the balloon causing distal displacement.Cook has concluded that the cause of the event cannot be traced to the complaint device and was most likely related to the procedure.The risk analysis for this failure mode was reviewed and no additional escalation was required.Cook 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.

Event Description

Additional/corrected information provided by the authoring physician: the patient was a 38-years-old gravida 3, parity 2 woman with 2 previous c-sections who delivered at 38 weeks of gestation via c-section delivery.Subsequently, the patient experienced post-partum hemorrhage (pph) due to uterine atony.A bakri tamponade balloon catheter was placed.After correct placement of the balloon inside the uterine cavity, the balloon is inflated with 350 ml saline however, there was no affect seen in reducing blood loss.When bleeding was controlled, it was observed that bakri balloon had displaced from uterine corpus to the lower segment of the uterus and inflation of the balloon caused a laceration of the very thin anterior wall of the uterine lower segment (due to previous cesarean surgeries).There was no balloon leakage or rupture the bakri balloon was immediately removed and patient was managed successfully with b-lynch uterine compression suture.The estimated blood loss of this case was 1200 ml and she received 2 units of packed red blood cells.

• 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: 8892260
• MDR Text Key: 154245032
• Report Number: 1820334-2019-02010
• 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
• Report Date: 09/12/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR