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

Model Number VFEM024

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

The device will be returned to edwards for evaluation.These cannulae are used to divert large volumes of blood between the patient circulation and the cardiopulmonary bypass machine during cardiac surgery and, on occasion, ecmo (off-label use).This malfunction/defect would likely require an exchange of the cannula resulting in a temporary interruption of bypass and possibly significant blood loss.Based on the information received the cause of the event cannot be determined.If additional information is received a supplemental mdr will be submitted.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

It was reported that 7 inches of a femoral venous catheter broke off inside of a patient during v-v ecmo after approximately 16 days.Placement site was the femoral vein.The catheter was removed in ir.The patient remained in the icu.

Manufacturer Narrative

H10.Additional manufacturer narrative: updated sections d4 (expiration date) and h4.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.

Manufacturer Narrative

H10: additional manufacturer narrative: updated section h6.Root cause inconclusive at this time.

• Brand Name: ADULT FEMORAL VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10898329
• MDR Text Key: 218208242
• Report Number: 3008500478-2020-00214
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K140208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2020

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: 03/04/2023
• Device Model Number: VFEM024
• Device Catalogue Number: VFEM024
• Device Lot Number: 63054742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/16/2020; 01/12/2021; 01/28/2021
• Supplement Dates FDA Received: 01/05/2021; 01/19/2021; 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention