MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FEMORAL ACCESS VENOUS CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number DVFEM018

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2014

Event Type  malfunction  

Event Description

As reported during use of adult femoral venous cannula, a leak was noted.The cannula was in use during 45 min, at this moment a leak was detected on the proximal end of the cannula, the cannula was not replaced, however, the user fixed the tubing material to stop the leakage.The procedure was not interrupted.There was not any instrument used to clamp the cannula.

Manufacturer Narrative

Device evaluation is anticipated, but has not yet begun.

Manufacturer Narrative

Device evaluation: the product was returned to edwards for evaluation and the complaint condition was confirmed.Visual analysis of the returned device found multiple damaged areas along the wirewound section of the device.Heavy damage was noted in the interface between the wirewound section and the hub overmold.The end proximal to the patient was clamped with forceps and water was flowed through the device using a 35ml syringe.Leakage was noted at the interface between the overmold and wirewound section.Additional manufacturer narrative: root cause is unable to be determined from the information available but it is possible that an application issue may have contributed to this event.No manufacturing defect can be confirmed.The instructions for use and risk control measures are appropriate at this time.Edwards will continue to review and monitor all events.

• Brand Name: FEMORAL ACCESS VENOUS CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: walt wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 4282579
• MDR Text Key: 5032880
• Report Number: 3008500478-2014-00140
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K123303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2014

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: DVFEM018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2015
• Initial Date FDA Received: 11/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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