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 Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

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

It was reported the female patient was injected with hemabate for postpartum hemorrhaging but it had no effect.The amount of bleeding reached 700 ml before the physician placed a cook bakri postpartum balloon with rapid instillation components.The physician placed the balloon transabdominally and used the enclosed syringe to fill the balloon with 200ml of saline and at the same time, the physician also sutured the uterus.After suturing was finished, they continued to inject saline.When the saline injected reached 350ml, the balloon ruptured and the saline flowed out.The balloon was removed and a 3cm longitudinal crack was found in the balloon.The physician changed to a new device and successfully stopped the bleeding.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation; the investigation included a review of complaint history, the device history record, drawings, instructions for use, quality control data, and specifications.A visual inspection of the returned device was also conducted.One device was returned for investigation.A visual examination noted the balloon material has a split.The device history record was reviewed and noted there was no non-conformance identified for this device lot number 6460741 related to the complaint report failure mode.A review of complaint history revealed there has been one other complaint associated with the complaint device lot number 6460741 for balloon rupture.The instructions for use (ifu) advises: the maximum inflation is 500 ml.Do not overinflate the balloon.Over inflation of the balloon may result in the balloon being displaced into the vagina.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.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the provided information a definitive root cause cannot be determined.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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
• MDR Report Key: 7177858
• MDR Text Key: 96846098
• Report Number: 1820334-2018-00041
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002242378
• UDI-Public: (01)10827002242378(17)181216(10)6460741
• Combination Product (y/n): N
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 02/19/2018
• Supplement Dates FDA Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 62