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 Problems Hemorrhage/Bleeding (1888); Uterine Perforation (2121)

Event Date 08/11/2014

Event Type  Injury  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported in the literature, a cook bakri balloon was used to treat a secondary postpartum hemorrhage fifteen days after cesarean delivery, and the uterus ruptured.One week after delivery, the patient developed abnormal bleeding and a pelvic ultrasound found retained tissue in the uterus.Ultrasound-guided aspiration was performed due to persistent bleeding.One week later, the patient was transferred to a maternity hospital with hemorrhagic shock and hemoglobin of 4.9 g/dl.Ultrasound noted retained placental tissue at the fundus and placenta accreta.A bakri balloon was inserted under ultrasound guidance and was inflated with 500 milliliters of fluid, paying attention to the cesarean scar.The bleeding continued and a laparotomy was performed, finding a frank rupture of the uterus next to an area of fundal placenta accreta, which was confirmed via histological analysis.A hysterectomy was then performed.The patient received eleven units of red blood cells, four units of fresh frozen plasma, one unit of platelets, four grams of tranexamic acid, and three grams of fibrinogen during the event.Thubert t., et al., 2014.Attention aux outils de tamponnement intra-utérin dans la prise en charge des hémorragies secondaires du post-partum.J gynecol obstet biol reprod (paris).Http://dx.Doi.Org/10.1016/j.Jgyn.2014.06.005.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported in the literature, a cook bakri balloon was used to treat a secondary postpartum hemorrhage fifteen days after cesarean delivery, and the uterus ruptured.One week after delivery, the patient developed abnormal bleeding and a pelvic ultrasound found retained tissue in the uterus.Ultrasound-guided aspiration was performed due to persistent bleeding.One week later, the patient was transferred to a maternity hospital with hemorrhagic shock and hemoglobin of 4.9 g/dl.Ultrasound noted retained placental tissue at the fundus and placenta accreta.A bakri balloon was inserted under ultrasound guidance and was inflated with 500 milliliters of fluid, paying attention to the cesarean scar.The bleeding continued and a laparotomy was performed, finding a frank rupture of the uterus next to an area of fundal placenta accreta, which was confirmed via histological analysis.A hysterectomy was then performed.The patient received eleven units of red blood cells, four units of fresh frozen plasma, one unit of platelets, four grams of tranexamic acid, and three grams of fibrinogen during the event.Investigation ¿ evaluation.A document based investigation was also performed including a review of the instructions for use and quality control data.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 made out of specification.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.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." "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." 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." "1.Determine uterine volume by direct examination or ultrasound examination." a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook concluded that off-label use contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.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

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: 12315819
• MDR Text Key: 266302845
• Report Number: 1820334-2021-01975
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• 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: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention