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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Shock (2072); Uterine Perforation (2121); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D2a.Common device name = unknown rpn, but is believed to be oqy intrauterine balloon d2b.Procode = unknown rpn.E1: customer (person) name/address/phone = unknown; literature complaint.E3: customer occupation = unknown; literature complaint.G4: pma/510(k) number = unknown rpn, however, the pma/510(k) number is believed to be k170622.F10: (annex e) additional code: e1420 - pelvic pain.H6: (annex e) additional code: e1420 - pelvic pain.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 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

As reported in a literature complaint, a 'bakri tamponade balloon catheter' had perforated the patient's uterus.A 39-year-old, female, patient delivered vaginally; 11-minutes after delivery, postpartum hemorrhage was identified.Vaginal and cervical lacerations were also identified and successfully sutured.Uterine atony was then noted and a 'bakri' device was placed and inflated to 500ml; hemostasis was achieved.After ~5 hours and 45 minutes, the patient reported abnormal pelvic pain and two ultrasounds were performed to confirm hemostasis, the device was then deflated to 400ml; no perforation was noted.Approximately 20 minutes later, the patient went into hemodynamic shock and a massive hemoperitoneum was identified.Explorative laparotomy was then performed concomitantly to resuscitation; upon exploration the user found an anterior uterine rupture and device migration through the right broad ligament with an irreversible wound of the right uterine artery with bleeding from the uterine and cervicovaginal arteries.The user experienced difficulty performing dissections and obtaining hemostasis due to pelvic edema.The user found the 'bakri' device had migrated into the abdominal cavity.The user performed a uterine rupture repair and ligation of the uterine vessels, cervicovaginal artery, and internal iliac artery, in order to achieve hemostasis.The patient was admitted to the intensive care unit and was released after 1 day.The user suspected the rupture of the broad ligament and the inferior segment could have occurred during inflation of the balloon which caused edema of the para uterine structures leading to rapid internal bleeding following deflation of the balloon.Cervical rupture was not considered as a cause of the migration of the device; after laparotomy, a cervical and vaginal examination found the cervix suture intact, and no path between the vaginal cavity was found.The patient received 11-units of red cells, 9-units of fresh frozen plasma, 2-units platelets, 2g of tranexamic acid, 8g of fibrinogen, 2-units of sulprostone, and 24h intravenous norepinephrine.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event description.As reported in a literature complaint, a 'bakri tamponade balloon catheter' had perforated the patient's uterus.A 39-year-old, female, patient delivered vaginally; 11-minutes after delivery, postpartum hemorrhage was identified.Vaginal and cervical lacerations were also identified and successfully sutured.Uterine atony was then noted and a 'bakri' device was placed and inflated to 500ml; hemostasis was achieved.After ~5 hours and 45 minutes, the patient reported abnormal pelvic pain and two ultrasounds were performed to confirm hemostasis, the device was then deflated to 400ml; no perforation was noted.Approximately 20 minutes later, the patient went into hemodynamic shock and a massive hemoperitoneum was identified.Explorative laparotomy was then performed concomitantly to resuscitation; upon exploration the user found an anterior uterine rupture and device migration through the right broad ligament with an irreversible wound of the right uterine artery with bleeding from the uterine and cervicovaginal arteries.The user experienced difficulty performing dissections and obtaining hemostasis due to pelvic edema.The user found the 'bakri' device had migrated into the abdominal cavity.The user performed a uterine rupture repair and ligation of the uterine vessels, cervicovaginal artery, and internal iliac artery, in order to achieve hemostasis.The patient was admitted to the intensive care unit and was released after 1 day.The user suspected the rupture of the broad ligament and the inferior segment could have occurred during inflation of the balloon which caused edema of the para uterine structures leading to rapid internal bleeding following deflation of the balloon.Cervical rupture was not considered as a cause of the migration of the device; after laparotomy, a cervical and vaginal examination found the cervix suture intact, and no path between the vaginal cavity was found.The patient received 11-units of red cells, 9-units of fresh frozen plasma, 2-units platelets, 2g of tranexamic acid, 8g of fibrinogen, 2-units of sulprostone, and 24h intravenous norepinephrine.Investigation ¿ evaluation review of the complaint history, device history record, instructions for use (ifu) and quality control (qc) procedures 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 for the complaint device could not be conducted nor could a search of other complaints associated with the complaint device lot number be completed, due to the lack of production lot information from the user facility.The product ifu, t_j-sosr_rev4 ¿bakri postpartum balloon,¿ provides the following information to the user related to the reported failure mode: contraindications: - "a surgical site that would prohibit the device from effectively controlling bleeding." warnings: - "this device intended as a temporary means of establishing hemostasis in cases indicating conservative management of postpartum uterine bleeding." - "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." precautions: - "avoid excessive force when inserting the balloon into the uterus." 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." based on the available information, no product returned, and the results of the investigation, the most probable cause of the reported event could not be determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 18134000
• MDR Text Key: 328109892
• Report Number: 1820334-2023-01565
• 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: Other,Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 39 YR
• Patient Sex: Female