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

Model Number RC014MIB

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Since the device is in the vasculature, component separation may result in embolization of that portion of the device.This may require retrieval which can often be done percutaneously.Attempts for retrieval are performed to prevent complications such as infection or thrombosis, which may occur in the short or long term.A definitive root cause could not be determined.As there has been no confirmed design defect, manufacturing issue, or inadequacy in the labeling, ifu, or training leading to the complaint, edwards will continue to review of all reported events and perform trend analysis on a monthly basis.If action is required based on the determined control limits, appropriate investigation will be performed.No corrective or preventative actions are required at this time.

Event Description

It was reported that a retrograde cannula was used for aortic valvuloplasty and the suture ring of the cannula fell off into the patient¿s body while removing the cannula from the patient.During use, the cannula was secured at opening of coronary sinus in right atrium.The cannula was secured at the suture ring by knotting suture.After removing the cannula, suture ring was missing.The surgeon searched for the suture ring, however, it was not found so that the chest was closed.Postoperatively, blood flow of pulmonary artery at lower lobe was not well possibly due to occlusion by the suture ring.The suture ring was found at inferior lobe branch of pulmonary artery in ct.The suture ring was removed via emergent catheter surgery next day.Patient status was reported as "no problem" and the patient is under monitoring at icu.

Manufacturer Narrative

Device evaluation: the product was returned for evaluation.Customer complaint of suture ring defect was unable to be confirmed.Suture ring was not returned with returned cannula when received by the product evaluation lab.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.All through lumens were found to be patent without any leakage or occlusion.No visual damage or other abnormalities were found to the returned device.Additional manufacturer narrative: manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7273735
• MDR Text Key: 100175397
• Report Number: 3008500478-2018-00057
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2019
• Device Model Number: RC014MIB
• Device Catalogue Number: RC014MIB
• Device Lot Number: 60691136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention