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

Catalog Number J-SOS-100500

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported the patient experienced a spontaneous delivery and postpartum hemorrhaging.The patient had lost 800 ml of blood.The physician found the liquid was floating from the vagina when he injected the saline with 100ml into the balloon.After the physician injected 200ml, the physician withdrew the device and found the middle of the balloon was ruptured.Lastly, the physician placed another band of balloons with 80ml saline in patient¿s uterus and successful hemostasis was established.No unintended portion of the device remained inside the patient¿s body.No additional procedures were required due to this occurrence.No adverse effects or consequences were reported to the patient due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: a visual inspection and functional testing of the returned device was performed.A review of complaint history, the device history record, drawings, and specifications was also conducted.One device was returned for investigation.A functional test determined the balloon material has a leak.A visual examination noted a cut in the material where the leak occurred.It appears the device was damaged during use.The complaint is confirmed.A review of the device history record found one (1) non-conformance associated with the complaint device lot number 8119173.The non-conformance was identified as labels, applied incorrectly.A review of complaint history revealed there has been no other complaint associated with the complaint device lot number 8119173.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.With the information available it is feasible to suggest that the damage was caused during the use of the device.Related to product use or handling; user technique.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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
• MDR Report Key: 7192880
• MDR Text Key: 97551462
• Report Number: 1820334-2018-00042
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)200804(10)8119173
• 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,other,user facili
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

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 Catalogue Number: J-SOS-100500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 02/23/2018
• Supplement Dates FDA Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 60