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

Model Number ISP3036

Device Problem Kinked (1339)

Patient Problem No Information (3190)

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Edwards received notification that during use of a venous duel stage cannula the basket section collapsed.As reported, the device was inserted through the central right atrium into the inferior vena cava and a kinked was noticed at the grey basket area.Venous return was lost.Upon removal of the cannula from patient the basket collapse was evident.

Manufacturer Narrative

Through further investigation, the cannula was used during the whole surgery and there were some flow issues during the case.Venous return was lost at the end of the surgery.The kink was noted upon removal of the cannula.

Manufacturer Narrative

Device evaluated by manufacturer: customer complaint of kinked gray band was confirmed.As received, the gray band of the cannula was found to be kinked, causing the cannula to bend more easily toward the kinked side.No other visible damage, contamination, or other abnormalities were observed from returned device.Further assessment is being conducted.When the further assessment is complete a supplemental mdr will be submit it.

Manufacturer Narrative

Through further evaluation of the subject device it was confirmed that the gray basket was not kinked.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.The complaint trend was assessed and it was found to be in control.A definitive root cause cannot be determined at this time.No further corrective or preventative actions are required.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: DUAL STAGE VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irivne CA 92614
• Manufacturer Contact: trushala nerurkar ; 1 edwards way; ms lfs33; irivne, CA 92614 ; 9492501377
• MDR Report Key: 6172170
• MDR Text Key: 62358045
• Report Number: 3008500478-2016-00041
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: ISP3036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/13/2017; 02/06/2017; 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2016
• 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