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

Model Number RC014T

Device Problems Contamination (1120); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

Customer report that "cannula body and the stylet of an rc014t cannula were found bent" was confirmed.As received, the stylet was inserted in the cannula and appeared bent at the blue heat shrink.Stylet met resistance when pulled out from the cannula.Upon removal of the stylet, the cannula body also appeared bent around the blue heat shrink area.Two unknown loose white particulates were found inside the tubing which was proximal of blue heat shrink.Sample was sent to chemistry lab for ft-ir analysis.Two surface scratches were observed on outer surface of the cannula body, proximal of the balloon.No other visual damage, contamination, or other abnormalities were found.The particulates were removed from the sample slide and scanned by diamond atr.Two particulates, measuring at 1057 micrometers by 3224 micrometers for an area measurement of 3,407,768 micrometers squared and 772 micrometers by 7667 micrometers for an area measurement of 5,918,924 micrometers squared.The ft-ir spectrum showed similar absorption characteristics to polycarbonate like material.Investigation is ongoing.A follow-up report will be submitted once additional information is available.

Event Description

Edwards received information that the cannula body and the stylet of an rc014t cannula were found bent when the customer opened the pouch before use.The cannula was not used, and the customer used another cannula.There was no contact with the patient, and there were no patient complications.The device was returned for evaluation.The device was stored horizontally on the shelf in the storage room at the hospital.When the sales rep received the device from the customer, he confirmed that some areas of the cannula body was discolored to a white, and whitish materials (approximately 1 to 2mm) were attached to the inside of the cannula body at the one of the whitish area.

Manufacturer Narrative

The device history record 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.Complaint confirmed.Ifu/labeling are adequate.Fmea line is adequate.Capa, scar, and pra are not required.Complaint trend is in control.Although a definitive root cause could not be conclusively determined, the stylet/cannula may have been damaged during shipment, storage, or handling.Based on the information available, an edwards/supplier defect/non-conformance regarding the bent stylet/cannula has not been confirmed.Based on the info available, the particulates were caused by the bent stylet scraping off material from the fll fitting.This is not a manufacturing non-conformance, but a side-effect of the bent stylet.

• Brand Name: RETROGRADE 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: 12073374
• MDR Text Key: 258710472
• Report Number: 2015691-2021-03793
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

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: 06/08/2023
• Device Model Number: RC014T
• Device Lot Number: 63211623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 07/15/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1