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

Model Number RC014T

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to edwards for evaluation.Evaluation is in progress.A definitive root cause could not be determined at this time.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported by the warehouse in (b)(4) that an unknown loose black particulate was found inside the tube of a retrograde cannula during incoming inspection.

Manufacturer Narrative

Device evaluation: japan warehouse reported that an "unknown loose black particulate" was confirmed.Upon closer examination, it was observed that the black particulate was on the inner lumen of the cannula and outer surface of the cardioplegia introducer.The unknown contaminant was easily wiped off of device tubing during examination with lab gloves.No other visual damage, contamination, or other abnormalities were found on sterile barrier packaging and product.Additional manufacturer narrative: updated expiration date and manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.Supplier, design, ifu and labeling defects were not confirmed.A manufacturing defect was confirmed.Trend is in control.Fmea line item is appropriate.Capa and pra action are required.Root cause will be investigated in capa.

Manufacturer Narrative

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

• Brand Name: RETROGRADE CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8790511
• MDR Text Key: 151280955
• Report Number: 3008500478-2019-00150
• 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,Followup
• Report Date: 06/21/2019

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: 04/22/2022
• Device Model Number: RC014T
• Device Catalogue Number: RC014T
• Device Lot Number: 62175635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 09/18/2019; 07/23/2020
• Supplement Dates FDA Received: 09/18/2019; 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1