MAUDE Adverse Event Report: EDWARDS LIFESCIENCES THIN-FLEX VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number TF022O90

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional investigation is underway.Additional information will be provided in a supplemental report.

Event Description

It was reported that during five (5) different cases, the tips of the 22 fr venous cannulae were not as stiff as usual.Per clinical opinion, the tips kinked easier than usual when the cannulae were warmed.The cannulae were inserted into the superior vena cava from the right atrium.Limited venous return was encountered.The cannulae were initially repositioned but then replaced with other cannulae.It is unclear if the exchange of the cannulae occurred prior to the initiation of bypass and full arrest of the heart.Additional information regarding the lot number(s) and when the events occurred was not available.There were no patient injuries in any of the cases.

Manufacturer Narrative

Manufacturing records were unable to be reviewed due to no lot number being provided by the customer.A manufacturing defect was not confirmed.The devices were not available for return.The complaint condition could not be confirmed.The 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.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

• Brand Name: THIN-FLEX VENOUS 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: neil landry ; one edwards way; m/s mle 8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5629416
• MDR Text Key: 44337752
• Report Number: 3008500478-2016-00013
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K120072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2016

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: TF022O90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2016
• 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
• Patient Sequence Number: 1