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

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that the physician performed a postpartum hemorrhage tamponade procedure by using bakri tamponade balloon catheter.Immediately after the procedure was started, the physician noticed a clear fluid from unknown source came into the drainage bag attached to the device.The physician did not irrigate the system prior to seeing the clear fluid.The physician completed the procedure by replacing the device with another bakri tamponade balloon catheter.The complainant did not report any adverse effects or significant treatment delay on the patient due to this occurrence.Additional information was requested regarding this occurrence; however it is not available at this time.

Manufacturer Narrative

Investigation ¿ evaluation: a review of visual inspection, specifications and quality control data was conducted during the investigation.One complaint device was returned for evaluation.Device evaluation revealed attached customer valve does not have a shut off which allows fluid to flow from drainage bag to balloon and vice versa.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the provided information and evaluation of the returned device, a definitive root cause cannot be established or reported at this time.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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6682089
• MDR Text Key: 78854156
• Report Number: 1820334-2017-01537
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• PMA/PMN Number: K013597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

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 Model Number: N/A
• Device Catalogue Number: J-SOS-100500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 02/27/2018
• 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