MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FEM-FLEX II FEMORAL ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number FEMII016A

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to edwards for evaluation.The clinical observation was unable to be confirmed.Manufacturing records were not reviewed as no lot number was provided.A definitive root cause cannot be determined at this time.No further corrective or preventative actions are required at this time.Edwards will continue to review and monitor all events through the use of edwards quality systems.

Event Description

Edwards received information that a femoral arterial cannula split in two after three hours in use.The cannula was inserted into the left femoral artery.It was reported that a few milliliters of blood loss occurred, but there were no patient complications due to this event.

• Brand Name: FEM-FLEX II FEMORAL ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irivne CA 92614
• Manufacturer Contact: trushala nerurkar ; one edwards way; ms lfs33; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6535210
• MDR Text Key: 74166993
• Report Number: 3008500478-2017-00025
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K140208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2017

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: FEMII016A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 05/01/2017
• 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