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

Model Number TF3646O

Device Problem Break (1069)

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

Event Date 11/10/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to edwards for evaluation.This device is inserted into the aorta during cardiac surgery.Cracks in the material may lead to loose fragments in the vasculature which could embolize distally and cause infarction.A definitive root cause could not be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification that this venous cannula was found damaged after use.As reported, the tip was broken after 4 hours of use.There was no reported injury for the patient who was noted as to be hospitalized in stable condition.

Manufacturer Narrative

Product evaluation: customer complaint that "tip was broken" on returned cannula was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, the tip of the returned cannula was cracked and flattened.No other visual damage, contamination, or other abnormalities were found to the device.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.

Event Description

Edwards received notification that this venous cannula was found damaged after use during an aortic dissection.As reported, the tip was broken after 4 hours of use.There was no reported injury for the patient who was noted as to be hospitalized in stable condition.There were reported no difficulties extracting the cannula.

Manufacturer Narrative

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

• Brand Name: 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: 8164403
• MDR Text Key: 131001277
• Report Number: 3008500478-2018-00096
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K120072
• 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: 11/22/2018

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: 05/14/2020
• Device Model Number: TF3646O
• Device Catalogue Number: TF3646O
• Device Lot Number: 60885845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Manufacturer Received: 11/22/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 01/09/2019; 07/23/2020
• Supplement Dates FDA Received: 01/29/2019; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1