MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; OQY INTRAUTERINE BALLOON

Model Number N/A

Device Problem Material Rupture (1546)

Patient Problem Hypovolemic Shock (1917)

Event Date 03/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event is still under investigation at this time.

Event Description

Initial information provided to the manufacturer on (b)(6) 2016 stated that an embolization procedure was being performed on the (b)(6) year old female patient.During use/after a c-section, the (b)(4) tamponade balloon catheter burst after introduction to the vaginal area.The device broke during filling of water.Additional information/clarification was provided on april 14, 2016 stating: the patient displayed hemorrhagic shock.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), quality control and visual inspection of the returned device was conducted during the investigation.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.The visual inspection of the returned device reported the device suffered a rupture / balloon burst.There is no evidence to suggest the product was not manufactured to specifications.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.The appropriate internal personnel have been notified.We will continue to monitor for similar complaints.

Event Description

Initial information provided to the manufacturer on 14march2016 stated that an embolization procedure was being performed on the (b)(6) female patient.During use/after a c-section, the bakri tamponade balloon catheter burst after introduction to the vaginal area.The device broke during filling of water.Additional information/clarification was provided on 14 april 2016 stating: the patient displayed hemorrhagic shock.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5651236
• MDR Text Key: 45090822
• Report Number: 1820334-2016-00292
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)190113(10)6518644
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/14/2016
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 31 YR