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

Model Number FEMII018A

Device Problems Loss of or Failure to Bond (1068); Crack (1135)

Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692); Multiple Organ Failure (3261)

Event Date 11/14/2019

Event Type  Death  

Event Description

Edwards received information of a cracked femii1018a cannula.The cracked cannula was found during use and had been indwelling for a minute when treatment started.The crack was located on the hub.The cannula was exchanged out.No serious injury related to the exchange.Patient outcome was reported as deceased.Picture of cannula package was provided.

Manufacturer Narrative

Device evaluation: device was returned with visible traces of blood and examined in the biohazard area of the lab.As received, the connector was observed to be slightly detached from the cannula body.A leak test was performed on the cannula and leakage was observed from the connector hub section.No other visual damage, contamination, or other abnormalities were found to the device.Additional manufacturer narrative: the device was returned to edwards for evaluation.Customer complaint of cracked femii1018a was confirmed with assessment.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.As reported, the cracked cannula was found during use.Inspections are in place at edwards during receiving and packaging to mitigate device damage.Damage due to shipping or clinical use cannot be ruled out.Neither a supplier nor an edwards¿ defect can be confirmed.A definitive root cause could not be identified.

Event Description

Patient expired four days later due to multisystem organ failure.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS LIFESCIENCES FEMFLEX II ARTERIAL AND FEMORAL CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9508825
• MDR Text Key: 207362234
• Report Number: 3008500478-2019-00180
• 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: 12/03/2019

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 Expiration Date: 07/15/2022
• Device Model Number: FEMII018A
• Device Catalogue Number: FEMII018A
• Device Lot Number: 62396283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/22/2019
• Supplement Dates Manufacturer Received: 01/19/2020; 07/23/2020
• Supplement Dates FDA Received: 02/11/2020; 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 54 YR