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

Model Number FEMII020A

Device Problem Split (2537)

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

Event Date 02/27/2014

Event Type  malfunction  

Event Description

It was reported by our collegues in (b)(6): during femoral insertion the introducer tip split and splintered.I have also collected two unused femoral peripheral access devices, femii 020a that are from the same lot number that the customers does not want to use.

Manufacturer Narrative

Evaluation into root cause is currently underway.

Manufacturer Narrative

During femoral insertion the introducer tip split and splintered.I have also collected two unused femii 020a that are from the same lot number that the customers does not want to use.Evaluation: visual inspection of the returned introducer found a section of the introducer to be missing.This is a confirmed manufacturing defect.The complaint was confirmed.Edwards has issued a product recall for this device concern.Manufacturing records were reviewed and there were no related nonconformances for this lot.The instructions for use and training are appropriate at this time.Trends will continue to be monitored through the edwards quality system.

• 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 ; 8015655200
• MDR Report Key: 3696551
• MDR Text Key: 4256067
• Report Number: 3008500478-2014-00043
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Model Number: FEMII020A
• Device Lot Number: 59350862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/27/2014
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2014
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2013
• 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