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

Model Number FEMII012A

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 03/02/2015

Event Type  malfunction  

Event Description

Edwards received information that upon discontinuation of a femoral arterial cannula a few millimeters of exposed wire were noticed at the tip area of the device.The 12 fr.Femoral arterial cannula was used in a pediatric patient for twenty-one (21) days for continuous percutaneous cardiopulmonary support (pcps).No damages were notice on the cannula prior to use.There were no patient complications reported.

Manufacturer Narrative

Device evaluation is pending.A supplemental mdr will be filed when evaluation is complete.

Manufacturer Narrative

Additional manufacturer narrative: the device was returned to edwards for evaluation and the complaint observation of exposed wire was confirmed.A visual examination was performed on the returned device condition as received.A wire protruding from the end of the reinforcing coil near the tip of the cannula was identified.No other obvious damage was noted.Further evaluation was performed and revealed there was a clear void in the cannula material corresponding to the shape of the protruding wire.A propagating tear in the layer of cannula material over the wire was found.The end of the protruding wire appeared to have residual material.The protruding wire was found to be slightly bent with a smooth curve and an interruption point at the end.The length of the protruding wire was found to be approximately 1.8 mm.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.Neither a product deficiency nor a manufacturing defect was identified.Based on the information received, a root cause could not be determined.The product instructions for use (ifu) was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The ifu provides the following warnings and precautions: ¿this device is intended for short-term use only (= 6 hours).Do not use if device shows signs of damage (i.E., cuts, kinks, crushed areas), or if package is damaged or open.¿ feedback was provided to the customer addressing the intended duration for usage of the device.This complaint is an isolated event and the trend is in control.No further action was required at this time.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

Event Description

Through follow-up with the sales rep, it was noted that when the femoral arterial cannula was received from the customer, approximately 2 millimeters of wire was exposed on the cannula but the wire was not sticking out from the cannula body as observed in edwards¿ product evaluation photos.It was possible device handling during transportation to the (b)(4) warehouse caused or contributed to the protruding wire seen in edwards¿ product evaluation photos.

• Brand Name: FEM-FLEX II PEDIATRIC FEMORAL ARTERIAL CANNULA
• 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: 4626610
• MDR Text Key: 5766020
• Report Number: 3008500478-2015-00022
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2015

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 Expiration Date: 04/01/2015
• Device Model Number: FEMII012A
• Device Lot Number: 59740476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 03/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2014
• 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