MAUDE Adverse Event Report: COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Catalog Number J-SOSR-100500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 09/30/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The area representative reported the female patient expired during treatment of a hemorrhage with a bakri balloon.Additional information was received after follow-up with the customer.The customer advised, they believe that the problem could have been caused by a clinical error on their part.As indicated, the valve of the bakri could have been bumped while the patient was being moved to a different bed causing the balloon to deflate.The intensive care unit (icu) nurse found the deflated balloon under the patient's back.The customer has not yet addressed all of cook's additional questions.They are still investigating this event.The customer commented they would like it if cook could modify the device to provide a protective locking mechanism for the valve that would prevent accidental deflation.

Manufacturer Narrative

Investigation ¿ evaluation: the cook (b)(4) postpartum balloon with rapid instillation components was not returned for evaluation.No photos have been provided.Without the complaint device, a physical investigation was not able to be completed.A review of documentation, instructions for use and specifications was performed.Based on the investigation 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; device integrity prior to shipping.These controls include that 100% of the stopcocks are visually examined for damage prior to release from manufacturing.The lot number of the complaint devise was not provided by the user facility however, a review of device manufacturing records for lots distributed directly to the reporting facility from (b)(6) 2014 through (b)(6) 2017 was performed.No non-conformances related to the reported issue were found.Additionally , a review of the complaint history was performed for similar complaints against the lot numbers of (b)(4) postpartum balloons shipped to the user facility from (b)(6) 2014 through (b)(6) 2017 and no similar complaints were found.There is no information regarding the patient¿s physical condition when the procedure was initiated.As advised in the instructions for use (ifu), ¿prior to transvaginal or transabdominal placement of the (b)(4) 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.¿ there is no information regarding the length of time between the delivery and start of the procedure.As documented in the ifu, ¿the (b)(4) postpartum balloon is indicated for use in the event of primary postpartum hemorrhage within 24 hours of delivery.¿ there is no information regarding the contents used to inflate the balloon or the inflation level.As found in the ifu, ¿always inflate the balloon with sterile liquid.Never inflate with air, carbon dioxide or other gas.Over inflation of the balloon may result in the balloon being displaced into the vagina.¿ there is no information regarding the length of time the device was indwelling.Per the ifu, ¿the device should not be left indwelling of more than 24 hours.¿ there is no information regarding any patient deterioration or interventions after placing the device.As stated in the ifu, ¿patient monitoring is an integral part of management of postpartum hemorrhage.Signs of deteriorating or non-improving condition should lead to a more aggressive treatment and management of patient uterine bleeding.¿ there is no information regarding any difficulties encountered with the device during the procedure.There is no alleged malfunction.There is no death certificate or autopsy report for review.At this time, clinical assessment cannot eliminate any possible causes for the patient death.Based on the information provided, the actual root cause is unknown and no conclusion can be drawn.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

Manufacturer Narrative

Additional detailed information has been received from the user facility regarding the patient and event.Please see the following updated fields.Patient identifier, age, weight.Date of event.Event details.Additional detailed information has been received from the user facility regarding the patient and event.Please see the following updated fields.Patient identifier, age, weight.Date of event.Event details.

Event Description

(b)(6) female patient delivered male infant (b)(6) 2017 @ 2056 hrs (8:56pm) by c-section (c/s).Patient was 41 weeks 4 days gestation.While the patient was still in the operating room (or), just after the c/s was completed, patient began hemorrhaging.Tocolytics were given along with blood products.At 2253 hrs (10:53pm) bakri balloon was placed resulting in adequate control of bleeding.On (b)(6) 2017 upon replacing clean pads under the patient, it was noted the bakri balloon had leaked and was in a decompressed state.Minimal bleeding initially noted, although gradually increased prior to replacement of another bakri balloon.Suspected cause of death (cod): cardiac arrest.As reported, no autopsy report has been received at this time from the medical examiner's office.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6976175
• MDR Text Key: 90197484
• Report Number: 1820334-2017-03518
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 28 YR
• Patient Weight: 80