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

Model Number N/A

Device Problems Unintended Ejection (1234); Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

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 that in order to treat a severe postpartum hemorrhage, the physician placed a cook bakri postpartum balloon with rapid instillation components inside the female patient's body and filled it with 250 ml of fluid followed by vaginal packing to keep it in place.It was noticed that the device expelled immediately after placing it.The physician also found a cervical laceration, however it is not sure if the laceration was already there or caused by the balloon.The patient could not be treated further and had to undergo a hysterectomy.No unintended section of the device remained inside the patient's body.The complainant did not report any adverse effects on the patient due to this occurrence.Additional information was requested regarding the failure of the device and the patient outcome; however it is not available at this time.

Manufacturer Narrative

Investigation - evaluation: a review of the instructions for use, specifications, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A document-based investigation evaluation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The instructions for use states the proper warnings, precautions, and instructions for use which lists hysterectomy as a contraindication.A device history record review could not be performed as the complaint lot number was not provided.Based on the provided information a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6681728
• MDR Text Key: 78852502
• Report Number: 1820334-2017-01590
• 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
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 07/25/2017
• Supplement Dates FDA Received: 08/10/2017
• 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): Other