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

Model Number E060

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2014

Event Type  No Answer Provided  

Event Description

Edwards received information that slivers of the plastic coating on the e060 stylette were noticed to be flaking off after reinsertion of the stylette.

Manufacturer Narrative

The clinical observation was confirmed.As received the device exhibited damage to the stylette coating.Edwards was able to recreate the damage during stylet removal or introduction.The damage to the stylet is caused by sylet interaction with the pvc hub during reinsertion.A field notification has been issued.

• Brand Name: VENT 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: 4208170
• MDR Text Key: 5041018
• Report Number: 3008500478-2014-00128
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2014

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: E060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 10/28/2014
• 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
• Removal/Correction Number: FCA051
• Patient Sequence Number: 1