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 Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Surgical procedure, additional (2564); Clotting (2600)

Event Type  Injury  

Event Description

Description according to the journal article bakri balloon effectiveness for postpartum hemorrhage: a "real world experience": "one pt had clots accumulated in the fundal region behind the balloon after placement.This may have been due to blood not passing through the drainage tubing or incomplete filling of the balloon within the uterine cavity initially.With this clot collection, the pt's uterus may have been unable to clamp down well and she underwent and ir procedure and eventually a hysterectomy.The balloon therapy may have masked continued bleeding in this pt and likely delayed definitive hemorrhage control.".

Manufacturer Narrative

(b)(4).Blood not passing through the drainage tubing or incomplete filling of the balloon within the uterine cavity.The event is currently under investigation.

• Brand Name: COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC - GYNECOLOGIC
• Manufacturer (Section D): COOK INC; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4745936
• MDR Text Key: 5885184
• Report Number: 1820334-2015-00238
• 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: Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2015

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 Catalogue Number: J-SOSR-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention