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

Model Number FEMII018A

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 12/20/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Edwards received information that during a mis mitral valve repair, a cannula could not be inserted in the femoral artery.It was decided to convert the procedure to a full sternotomy due to not being able to insert the cannula into the femoral artery.The cannula was noted to be in good condition and was placed in the ascending aorta without any difficulty.At the time of connecting the cannula to the heart lung machine, it was noticed that the vented connector broke.It was reported that there was no extra force used and the patient lost approximately 500-600ml of blood in the first 30 minutes due to the broken vented connector of the cannula.The cannula was replaced and the procedure was completed without any other issues.The patient was reported to be hospitalized in stable condition.

Manufacturer Narrative

Device evaluated by manufacturer: customer complaint of broken vented connector was unable to be confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.Red vent cap was not returned with device.Cannula vent connector where red vent cap is connected to was observed to be undamaged.As received, a kink was found on the wire reinforced section of the cannula body near the suture ring.A cut was also found on the suture ring of the device.Cannula connector was examined and no damages were found.Lab sample white luer cap was firmly attached on and easily detached without any complications.No other visual damage, contamination, or other abnormalities were found.

Manufacturer Narrative

Through further investigation, it was learned that a tangentially crack in the connector was noticed.The blood leak dripped down from another point of the cannula.Further assessment of the device was performed due to the additional information.A leak test was conducted and no leaks were found on the device.

Manufacturer Narrative

Through assessment of the subject device, the reported complaint was unable to be confirmed.A manufacturing deficiency was no identified.A definitive root cause cannot be determined.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.The complaint trend was assessed and it was found to be in control.No further corrective or preventative actions are required at this time.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: FEM-FLEX II 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: truahala nerurkar ; 1 edwards way; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6258304
• MDR Text Key: 65025475
• Report Number: 3008500478-2017-00004
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140208
• 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: 12/23/2016

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 Model Number: FEMII018A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2016
• Initial Date FDA Received: 01/17/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/20/2017; 02/01/2017; 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 55 YR
• Patient Weight: 102