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

Lot Number UNKNOWN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Date of event:: 2015-2016.Catalog number: j-sos-100500 or j-sosr-100500.Reporter name and address: postal code: (b)(6).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 in "effect of routine rapid insertion of bakri balloon tamponade on reducing hemorrhage from placenta previa during and after a cesarean section" appearing in the 24jun2017 edition of the archives of gynecology and obstetrics (296:469-474), five patients experienced increased hemorrhage due to prolapse of the balloon from the uterus after the operation.These 5 cases are reported in this report, and patient identifier (b)(6), patient identifier (b)(6), patient identifier (b)(6), and patient identifier (b)(6).Available details and sequence of events are a follows: at the beginning of the cesarean delivery (and again 12hours post-operatively), an unspecified antibiotic was administered intravenously.During cesarean section delivery (for the indication of placenta previa), after infant delivery, oxytocin 5iu in a 500ml saline drip was started intravenously (and continued for 24 hours after the cesarean delivery).Following spontaneous separation of the placenta, a bakri tamponade balloon was filled with 50ml of distilled water and immediately inserted into the lower uterine segment through the incision site of the uterus after checking for any retained placental fragments.The uterine incision was then closed using double-layer suturing.After skin closure, the bakri tamponade balloon was inflated with 100-150ml of water until the bleeding was obviously decreased.The bakri tamponade balloon was then fixed in the appropriate position under transabdominal ultrasound guidance, and vaginal packing was placed to prevent prolapse of the bakri from the uterus.An unspecified time later (less than 24 hours), the bakri tamponade balloon spontaneously prolapsed from the uterus.The bakri was re-inserted and no further hemostatic management was required.There were no complications related to bakri insertion such as infection or uterine rupture.Post-operative blood loss was between 950 grams and 2150 grams (when quantifying blood loss 1gm=1ml).It is not known how much of the post-operative blood loss occurred prior to the bakri prolapse, and how much occurred after.No additional consequences to the patient have been reported 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

Event description: patient experienced increased hemorrhage due to prolapse of the balloon from the uterus after placement and inflation.The hemorrhage was controlled by balloon re-insertion without additional hemostatic procedures.Additional incident details were repeatedly requested from the complainant, but were not provided.No adverse events were reported.Investigation - evaluation: reviews of 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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A review of the device history record and complaint history could not be completed due to lack of lot information from the user facility.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: "2.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." "note: to prevent displacement of the balloon of the balloon into the vagina, counterpressure can be applied by packing the vaginal canal with iodine- or antibiotic-soaked gauze." a clinical assessment of the reported incident concluded that the most likely contributing factors include patient condition (significant risk factors for post-partum hemorrhage including caesarean delivery and placenta previa), and failure to follow the ifu.Less likely potential causes include a manufacturing defect.A definitive cause of the reported incident could not be determined from the available information.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue to monitor for similar complaints.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

There is no new patient or event information to report.

• 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: 10430376
• MDR Text Key: 203670837
• Report Number: 1820334-2020-01519
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other