MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Model Number N/A

Device Problem Deflation Problem (1149)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 07/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported that a bakri tamponade balloon catheter was used on the female patient who had a c-section to control uterine bleeding.The balloon was placed in the uterus and inflated with 150ml sterile water.The next day the physician attempted to withdraw the balloon but could not aspirate the fluid from the balloon to deflate for removal.The balloon was deflated by puncturing the balloon trans-vaginally and removed from the uterus.Patient outcome unknown as information not provided by reporter.

Manufacturer Narrative

(b)(4).A review of the documentation, instructions for use (ifu), specifications, and visual inspection of the returned device was conducted during the investigation.One bakri tamponade balloon catheter was returned for investigation.A visual examination of the returned device noted the balloon catheter had an unidentified tube inserted into the inlet, blocking the inflation lumen.An attempt to deflate the balloon with the unidentified device in place was unsuccessful.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• 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 ; 8128294891
• MDR Report Key: 5830841
• MDR Text Key: 50713437
• Report Number: 1820334-2016-00754
• Device Sequence Number: 1
• Product Code: KNA
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

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-SOS-100500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: 06/29/2017
• Supplement Dates FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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