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

Model Number TF018L

Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Device-Device Incompatibility (2919)

Patient Problem Death (1802)

Event Date 09/17/2019

Event Type  Death  

Manufacturer Narrative

Additional manufacturer narrative: it was reported that the blood drainage flow of the venous cannula was restricted and not adequate.The subject device has been returned for evaluation and analysis is in progress.Once the evaluation is complete, a supplemental report will be submitted accordingly.

Event Description

As reported, a venous cannula apparently did not function according to specification and the blood drainage flow of the cannula was restricted.The cannula was used to connect the vena cava to the pump machine during a coronary bypass surgery involving a pediatric patient.It was reported that the distal hole on the 18 fr.Cannula (subject device) had a small diameter (it was compared and found smaller than the distal hole on the 16 fr.Cannula).The patient expired and the cause of death has not been determined.

Manufacturer Narrative

Device evaluation: customer reports that cannula "did not function according to specification" and restricted drainage flow were not confirmed with assessment.As received, two cannulas, a 18 fr.Model and a 16 fr.Model, were connected to a y connector.The inner diameter (id) of the 18 fr.Cannula tip was measured using pin gauge set.Id measurement of cannula tip was 0.062", which was in specification.No visual damage, contamination, or other abnormalities were found to the device.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.Manufacturing, supplier, design, ifu, and labeling defects were not confirmed.Trend is in control.Capa and pra are not required.Root cause cannot be determined at this time.

Event Description

Edwards received a notification from a hospital asking about the specifications of a venous cannula.As reported, a pediatric patient expired during the use of the venous cannula.As reported, restricted blood flow was noted in the case, and upon visual inspection by the hospital, the 18 fr.Cannula tip hole appeared to be smaller than the tip hole of the 16 fr.Cannula.The site proposed that the smaller tip hole on the larger cannula may have contributed to the intraoperative blood flow disturbances.After product specifications were communicated by edwards to the hospital, the facility was satisfied that there was no manufacturing non-conformance or design problem of the 18 fr.Cannula and retracted their allegation of device relationship to the reported event.

Manufacturer Narrative

H11.Corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

Manufacturer Narrative

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

• Brand Name: THIN-FLEX VENOUS RETURN CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9182995
• MDR Text Key: 162244144
• Report Number: 3008500478-2019-00162
• 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,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2021
• Device Model Number: TF018L
• Device Catalogue Number: TF018L
• Device Lot Number: 61394908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death