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

Model Number VFEM022

Device Problems Deformation Due to Compressive Stress (2889); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

If the device is used for ecmo (off-label use): in these cases, the cannulae are used for an extended period of time, much longer than the 6 hours indicated in the instructions for use.In the case of a leakage, exchange of the device will require temporary interruption of ecmo circuit, which could potentially result in injury to the patient.The device return follow-up is in progress.If new information becomes available, a supplemental report will be submitted.

Event Description

Edwards received information that air was aspirated to a cannula during use.The cannula had been used for circulatory support with v-v ecmo for nineteen (19) days due to acute respiratory distress syndrome.While the area where the air was aspirated was not identified clearly, it could have occurred near the boundary area between the wire-reinforced area and the non-reinforced area at proximal side of the cannula.The air was not into the patient¿s body, and there were no adverse patient events reported.

Manufacturer Narrative

H10: additional manufacturer narrative.Updated f10, h3, and h6 per new information received.H3: product evaluation.Customer complaint of "air was aspirated to a vfem022 cannula" was not confirmed with assessment.Device was returned with visible traces of blood and examined in the biohazard area of the lab.As received, multiple wire reinforced sections of the cannula body were observed to be kinked.A leak test was performed on the cannula and leakage was not observed at both the proximal and distal ends.No other visual damage, contamination, or other abnormalities were found to the device.

Event Description

Edwards received information that air was aspirated to a cannula during use.The cannula had been used for circulatory support with v-v ecmo for nineteen (19) days due to acute respiratory distress syndrome.A disinfectant was applied at the insertion site.While the area where the air was aspirated was not identified clearly, it could have occurred near the boundary area between the wire-reinforced area and the non-reinforced area at proximal side of the cannula.The cannula was exchanged with another cannula of the same model and v-v ecmo was continued to use for the patient.The patient was weaned off from v-v ecmo after twenty-four (24) days of use, however, v-v ecmo was restarted and has continued to use for circulatory support.The patient status was reported as ¿under treatment¿ in icu.The air was not into the patient¿s body, and there were no adverse patient events reported.

Manufacturer Narrative

The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: FEMEROL VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10968568
• MDR Text Key: 220224292
• Report Number: 3008500478-2020-00215
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2020

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: 09/30/2020
• Device Model Number: VFEM022
• Device Catalogue Number: VFEM022
• Device Lot Number: 62605738
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/16/2020; 02/04/2021
• Supplement Dates FDA Received: 01/13/2021; 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention