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

Model Number TF018L

Device Problems Restricted Flow rate (1248); Inadequacy of Device Shape and/or Size (1583); Defective Component (2292)

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 cannulas was restricted and not adequate.The root cause of these events cannot be conclusively determined with the available information.Requests for additional information are currently in progress.Edwards lifesciences will continue to monitor all reported events.If any new information is received, a supplemental report will be submitted accordingly.

Event Description

As reported, 5 venous cannulas apparently did not function according to specification and the blood drainage flow of the cannulas was restricted.The cannulas were used to connect the vena cava to the pump machine during coronary bypass surgeries involving 5 pediatric patients.It was reported that the distal hole on the 18 fr.Cannula (subject devices) had a small diameter (it was compared and found smaller than the distal hole on the 16 fr.Cannula).The patients expired and the causes of death have not been determined.The hospital had devices from two different lots (61148102, 61394908).

Manufacturer Narrative

The device history record (dhr) 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.The device was not returned to edwards for evaluation; however, pictures were provided.Customer report the cannula "did not function according to specification and the blood drainage flow of the canulae were restricted" could not be confirmed through image evaluation.Two photos were provided of model tf018-l cannula body and tip.The cannula tip of the 18fr appeared smaller than the 16fr and 20fr cannula models.Clinical root cause could not be determined at this time.Udi number: (b)(4).

Manufacturer Narrative

Corrected data: updated section event or problem.

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

Corrected data: updated sections event and (lot number).

Event Description

In one case, a venous cannula apparently did not function according to specification and the blood drainage flow of the cannula was restricted.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).However after doing more thorough measurements, the tip holes of the cannulae measured the same as other tf0.18l cannulae from another hospital, and not smaller.The patient expired.

Manufacturer Narrative

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: 9182997
• MDR Text Key: 162244253
• Report Number: 3008500478-2019-00163
• 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,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: 11/16/2020
• Device Model Number: TF018L
• Device Catalogue Number: TF018L
• Device Lot Number: 61148102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death