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

Model Number FEMII018A

Device Problems Leak/Splash (1354); Appropriate Term/Code Not Available (3191)

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

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record (dhr) review could not be performed as the lot number is unknown.The device is expected to be received for evaluation.A supplemental mdr will be submitted once new information is received.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.

Event Description

Edwards received information a femoral arterial cannula was leaking while on an ecmo patient in the perfusion "kitchen." the patient was returned to the operating room and the cannula was changed out.Device is available for return.Patient is still on ecmo.Location of leak was 4 inches from the insertion site.Leak was noted less than 24 hrs from placement.

Manufacturer Narrative

Device evaluation: device was returned with visible traces of blood and examined in the biohazard area of the lab.As received, wire reinforced section of the cannula body was observed to be kinked.A leak test was performed on the cannula and leakage was not observed from the cannula body.No other visual damage, contamination, or other abnormalities were found to the device.Additional manufacturer narrative: attempts to retrieve additional information were unsuccessful.The device was returned for evaluation.Customer complaint of cannula leakage was not confirmed with assessment.Neither a supplier nor an edwards' defect could be confirmed.The cause of the kink could not be determined as the kink was noted after clinician use, during product evaluation.Additionally, this device was used for extra corporeal membrane procedure which is off-label use.It is possible that any damage noted to the cannular during clinician use resulted from customer device use that did not align with the intended use for the design.A definitive root cause could not be identified as the customer complaint of leakage was not confirmed with assessment.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: FEMORAL ARTERIAL 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: 9191035
• MDR Text Key: 207361005
• Report Number: 3008500478-2019-00164
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K12329824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2019

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: FEMII018A
• Device Catalogue Number: FEMII018A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 12/04/2019; 07/23/2020
• Supplement Dates FDA Received: 12/19/2019; 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR