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

Model Number RC2012

Device Problems Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation nd the (b)(6) reported that a "knick was found on the stylet inside the balloon inflation line" was not confirmed.It was observed that the knick was a clear loose particulate.Upon closer examination, it was observed that the clear loose particulate was on the inner tubing of the cannula.No other visual damage, contamination, or other abnormalities were found on sterile barrier packaging and product.The device was sent to chemistry lab for ft-ir analysis.The particulate was removed from the sample slide and scanned.Particulate was measuring at 1619 m by 1672 m for an area measurement of 2,706,968 m².The ft-ir spectrum showed similar absorption characteristics to polyester foam like material.An engineering task was performed and a supplier, design, ifu, and labeling defect were not confirmed.A manufacturing defect was confirmed.The trend was reviewed and found to be in control.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.The loose particulate found inside lumen of device in sealed pouch was likely due to not following procedures.Corrective and preventative action will be initiated for this issue.

Event Description

It was reported by the warehouse in (b)(6) that a knick was found on the stylet inside the balloon inflation line of the smooth balloon retrograde cannula during incoming inspection.The device was returned for evaluation.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa (b)(4).

• Brand Name: RETROGRADE CARDIOPLEGIA CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9787727
• MDR Text Key: 202428595
• Report Number: 3008500478-2020-00190
• 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
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

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: 10/17/2022
• Device Model Number: RC2012
• Device Catalogue Number: RC2012
• Device Lot Number: 62664287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 09/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1