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

Catalog Number J-SOS-100500

Device Problem Material Rupture (1546)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

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.

Event Description

It is reported during tamponade of post partum hemorrhage (due to placenta accreta) using a cook bakri tamponade balloon catheter, the balloon broke 3 hours after placement.The bakri tamponade balloon catheter was placed transvaginally after the patient had experienced a 1000 ml blood loss.A second bakri tamponade balloon catheter was placed and hemostasis was achieved.The total volume of blood loss was not provided, however it was reported at the point that the patient had lost about 2000 ml of blood, the patient was given transfusion of 5 units of blood.The patient had no history of prior full-thickness hysterotomy or pre-existing coagulation disorder.Additional details were requested regarding the patient, but this information was not provided.

Manufacturer Narrative

Investigation ¿ evaluation.The device was not returned for an evaluation.Without the device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of the instructions for use, quality control data, and trends.Clinical assessment: the patient had no history of prior full-thickness hysterotomy or pre-existing coagulation disorder.For this patient, we don¿t have complete information about her risk factors for post-partum hemorrhage such as retained placental fragments, prolonged oxytocin administration prior to delivery, polyhydramnios, obesity, vaginal/cervical lacerations, placental attachment abnormalities, or hispanic or asian ethnicity.It was reported that the patient possibly had diabetes or a multiple gestation delivery (both of which would increase postpartum hemorrhage risk), but this information could not be confirmed.The instructions for use (ifu) provides the following relevant information: precautions: avoid excessive force when inserting the balloon into the uterus.Instructions.Transvaginal placement: 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.Place an indwelling urinary bladder foley catheter at this time, if not already in place, to collect and monitor uterine output.Transabdominal placement, post-cesarean section: determine uterine volume by direct examination.From above, via access of the cesarean incision, pass the tamponade balloon, inflation port first, through the uterus and cervix.Note: remove and stopcock to aid in placement and reattach prior to filling balloon.Have an assistant pull the shaft of the balloon through the vaginal canal until the deflated balloon base comes into contact with the internal cervical ostium.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 close.Note: if clinically relevant, a b-lynch compression suture may be used in conjunction with the bakri postpartum balloon.A review of the device history record could not be performed as the user facility did not provide the lot number of the device.A review of complaint history for the complaint device lot also could not be performed as the lot number was not provided.The complaint device was not returned for evaluation.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The definitive cause of the event is unknown, although because the device was placed transvaginally before the hysterotomy was closed, it is possible the balloon was inadvertently punctured during the suturing of the uterus.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Monitoring will continue to be performed for similar complaints.The appropriate cook personnel have been notified of this event.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

No additional event information has been provided since the last 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: 8516473
• MDR Text Key: 142044414
• Report Number: 1820334-2019-00779
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other