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

Model Number FEMII016A

Device Problem Bent (1059)

Patient Problem Death (1802)

Event Date 01/17/2014

Event Type  Death  

Manufacturer Narrative

The device was not released by the hospital for evaluation.This mdr is related to the same investigation and actions as mdr 3008500478-2014-00015.It was reported that the fem-ii arterial cannula obturator split when placed into the vessel.Follow up with the customer ((b)(6)) on (b)(6) 2014 via phone: reported that there were three fem-ii that were used in this case.The first two "crumbled" when removed from the package and were not used with the patient.The third was found to have a bent tip and was inserted femorally into the patient.The patient came to the hospital presenting influenza a and pneumonia.The patient when into adult respiratory distress syndrome and was put on ecmo.Pt expired during use of the device.Evaluation: the device was not released by the hospital for evaluation.Manufacturing records were unable to be reviewed due to no lot number provided by the customer.However, evidence from similar complaints have identified this report to be consistent with issues that customers have experienced that are being addressed through edwards complaint and risk management systems.The complaint was confirmed.Through complaint analysis and capa investigation the root cause of this was determined to be variation in a supplier process creating cracks on the tip of the dilator.At this point and time the information provided indicates that the cause of death was related to respiratory distress due to the influenza a and pneumonia for which the patient was put on ecmo and not cardiac infarction due to the device.The labeling and ifu were assessed for adequacy and are considered acceptable at this time.A recall was initiated as part of the edwards risk management system and is being tracked through the field corrective action system.

Event Description

It was reported that the fem-ii arterial cannula obturator split when placed into the vessel.Follow up with the customer on (b)(4) 2014 via phone: reported that there were three fem-ii that were used in this case.The first two "crumbled" when removed from the package and were not used with the patient.The third was found to have a bent tip and was inserted femorally into the patient.The patient came to the hospital presenting influenza a and pneumonia.The patient when into adult respiratory distress syndrome and was put on ecmo.Pt expired during use of the device.

Manufacturer Narrative

At this time, the cause of death is unknown but patient was critically ill on ecmo.

• Brand Name: FEMORAL ARTERIAL 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: walt wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 3699350
• MDR Text Key: 11752413
• Report Number: 3008500478-2014-00044
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/27/2014

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 Model Number: FEMII016A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2014
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 03/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2014
• 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
• Patient Outcome(s): Death
• Patient Age: 41 YR
• Patient Weight: 94