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

Catalog Number J-SOS-100500

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Pma/510(k) #: k170622.(b)(4).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 the patient experienced postpartum hemorrhage.The bakri tamponade balloon was placed through the vagina and inflated with 200ml saline, then leakage was noted.After the leakage was found, the balloon was immediately removed and pressure used to stop bleeding.A uterine artery embolization procedure was performed with blood transfusion.Additional event and patient information has been requested.At the time of this report, no further information has been forthcoming.

Manufacturer Narrative

Investigation ¿ evaluation.A visual inspection and functional testing 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, quality control data, and specifications.One device returned for investigation.The returned packaging confirms the customer reported lot number.The device was returned without the balloon portion.Functional testing was performed.The center portion of the stopcock was found to be broken, resulting in a leak.The device history record was reviewed and no non-conformances were identified that would have caused or contributed to the reported failure mode.A complaint history search revealed this is the only complaint associated with the complaint device lot.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: warnings: 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.Patient monitoring is an integral part of managing postpartum hemorrhage, signs of deteriorating or non-improving condition should lead to a more aggressive treatment and management of patient uterine bleeding.100% of stopcocks are inspected prior to shipping, therefore the stopcock was most likely broken after distribution.This complaint is confirmed based upon evaluation of the returned device.It has been concluded that the broken stopcock contributed to the balloon device leaking.The cause of the broken stopcock could not be determined.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Cause traced to component failure.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Cook medical has notified the appropriate personnel and 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

Additional information that was received that was not reported on the follow up 1 report: it was reported, after separation of partial adhesion, right lower uterine ring suture was performed and oxytocin, carprost, and tromethamine injection were used to treat the post- partum hemorrhage.After interventional embolization, the patient was transferred to the intensive care unit (icu) and was discharged after 6 days of rehabilitation.

Event Description

Additional information was provided on 11mar2019.Placenta previa was diagnosed prenatally.Implantation and adenomyosis were found during the procedure.Leaking was noted approximately 10min after placing the balloon.Just about to suture the lower uterine incision.The uterine artery embolization and blood transfusions were needed due to the underlying pathology.Extensive adhesion between the posterior wall of the uterus and the pelvic cavity due to placenta previa with implantation and adenomyosis.Upper branch suture of uterine artery and b lynch suture could not be performed.Total blood loss was 3900ml.The patient received oligoplasma 13units, plasma 1300ml, platelets 10units, and cryoprecipitate 20units.The device lot number is 8139425.The device will be returned for evaluation.

Manufacturer Narrative

The complaint device has been received and the investigation remains in progress.A follow up report will be submitted should additional relevant information become available or upon completion of the investigation.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.

• 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: 8405165
• MDR Text Key: 138289112
• Report Number: 1820334-2019-00594
• 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: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 8139425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 04/02/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 76