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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this report indicate the information is not available or unknown.(b)(4).This event is still under investigation at this time.

Event Description

The female patient had a caesarean section due to placenta previa.Although there was no bleeding; the user decided to place bakri tamponade balloon catheter for preventive purpose since poor uterine contraction was observed.The balloon would not inflate in the uterus and it seemed the saline was leaking from the balloon.The balloon was removed and a pinhole was noted near the joint line of the balloon material near the center.The balloon was replaced.No bleeding occurred and the balloon was removed next day.No adverse effects to the patient.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, functional test, device history record, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported using a microscope; a hole was visible in the balloon material.A functional test was performed.Using a syringe, the balloon was inflated with water; a leak was noted in the balloon.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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 ; 8123392235
• MDR Report Key: 6110152
• MDR Text Key: 60317478
• Report Number: 1820334-2016-01434
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)190623(10)7071546
• Combination Product (y/n): N
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOS-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2016
• 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