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

Model Number FEMII010A

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 01/15/2015

Event Type  malfunction  

Event Description

Edwards received information that a customer noticed the surface of a 10 fr arterial cannula, near the end of the wire at the tip, seemed thin and shiny when inspecting the device prior to patient use.Also noted, the surface of the cannula tip next to thin area was slightly projected, so it felt bumpy when the customer touched the surface with his finger.The cannula was not used.

Manufacturer Narrative

Device evaluation currently underway.

Manufacturer Narrative

Additional manufacturer narrative: the device was returned to edwards for evaluation and the reported condition was confirmed.Visual inspection of the returned device found approximately 1mm of coiled wire exposed at 0.5mm proximal from the end of the wire around the cannula tip.To further investigate this reported complaint condition bench top testing was performed to evaluate worst case simulated use conditioning.There was no change in the level of exposed wire as a result of worst case simulated use conditioning which included simulated insertion/retraction and device hydration.The results of this testing support our updated assessment that exposed wire has no impact to patient safety.Manufacturing records were reviewed and no related non conformances were identified.The product evaluation confirmed a manufacturing defect.Corrective actions are in process through the use of the edwards quality system.The ifu was reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Edwards will continue to review and monitor all events.

• Brand Name: FEMORAL ARTERIAL CATHETER
• 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
• MDR Report Key: 4495559
• MDR Text Key: 5567599
• Report Number: 3008500478-2015-00014
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2015

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: 05/01/2017
• Device Model Number: FEMII010A
• Device Lot Number: 59792415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 02/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2014
• 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