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

Catalog Number J-SOS-100500

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Hemorrhage/Bleeding (1888); Hypovolemic Shock (1917); Multiple Organ Failure (3261)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported, "during the process of cesarean section, the patient was suffered postpartum haemorrhage due to dangerous placenta previa.The amount of bleeding reached 1300ml before place this device.The patient was given oxytocin, ergometrine and hemabate to hemostasis but failed.So bakri balloon was used to stop bleeding.The physician placed the balloon into the uterine cavity through the incisions, then injected with 60 ml saline and the physician sutured of the uterus incision, then the physician continue to injected with 300ml saline.Then the physician checked and found a large amount of fluid leak out from uterus incision.So the physician removed the balloon and found the balloon was longitudinal ruptured and leaking.At this moment, the amount of bleeding reached 2500ml so the physician changed another new balloon to use, but the patient had severe bleeding and could not stop.At last, the patient had to have a hysterectomy.The patient has suffered from hemorrhagic shock, lung failure and respiratory failure due to excessive bleeding." the following additional information was provided during follow up with the customer.There were no reported complications experienced during the pregnancy.The patient had a previous c-section in 2014.This is the patient's second pregnancy.The patient's membranes ruptured at (b)(6) gestation.The patient had a partial uterine implantation of the placenta.Cesarean section was required due to dangerous placenta previa, placenta accrete and scarred uterus diagnosed antepartum.The physician placed the balloon into the uterine cavity through the incisions by hand.No other devices were used.The device was partially inflated (60ml) prior to hysterotomy incision suturing.The user knows the suture needle may have damaged the balloon.The patient was given 8000 ml of blood.Post hysterectomy, the patient was transferred to another hospital and sent to icu with hemorrhagic shock, multi-organ dysfunction syndrome (mods), placenta previa, pulmonary infection and hysterectomy.On (b)(6) 2018, it was reported, the patient was awake, spontaneous breathing, and "showing great improvement".Bakri postpartum balloon intended use this device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.Contraindications (.) cases indicating hysterectomy.Warnings: this device is intended as a temporary means of establishing hemostasis in cases indicating conservative management of postpartum 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.Transabdominal placement, post-cesarean section: (.) close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing.Note: ensure that all product components are intact and the hysterotomy is securely sutured prior to inflating the balloon.If clinically relevant, the abdomen may remain open upon inflation of the balloon to closely monitor uterine distention and confirm the hysterotomy closure.Note: if clinically relevant, a b-lynch compression suture may be used in conjunction with the bakri postpartum balloon.

Event Description

There has been no new information relevant to the complaint description received since the last report was submitted.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, instructions for use, and specifications.The customer returned one bakri balloon rpn j-sos-100500 and lot number 8481304 for physical evaluation.A visual examination noted the device has a 6.5 cm split in the balloon material.A review of the device history record found no non-conformances that may have contributed to this failure mode.A complaint history search revealed this is the only complaint associated with lot number 8481304.A review of the current versions governing the manufacturing and quality controls was conducted.This review surmised that the current process and quality inspection checks are in place to ensure the functionality and device integrity prior to shipment.No specific issue that may have contributed to this failure mode was found, and the complaint devices were found to be manufactured within specification.Potential contributing factors that lead to this failure are improper maintenance of the balloon, balloon puncture during the suturing process, and over inflation of the device.It was noted that the balloon was placed through the cesarean incision but it is not known if it was placed inflation port first.The instructions for use (ifu) states to have assistant pull the shaft of the balloon through the vaginal canal until the deflated balloon base comes in contact with the internal cervical ostium.Close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing.According to the customer, the balloon was inflated prior to suturing the device.It is feasible to suggest the balloon may have been punctured during suturing.The definitive cause for this specific failure is not able to be established.The risk analysis for the rupture or leakage of the balloon was reviewed.Measures have been initiated to address this failure mode.The appropriate personnel have been notified and the manufacturer will continue to monitor this device for similar complaints.

• 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: 7798536
• MDR Text Key: 117693143
• Report Number: 1820334-2018-02342
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)210102(10)8481304
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2021
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 8481304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Date Manufacturer Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 29 YR
• Patient Weight: 72