MAUDE Adverse Event Report: EDWARDS LIFESCIENCES VENOUS RETURN CANNULA OPEN TIP; VENOUS CANNULAE

Model Number TF024O90

Device Problems Restricted Flow rate (1248); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

Cannulae that compress or collapse during use, in a worst case scenario, may kink and impede blood flow during cardiopulmonary bypass.Unlike issues that involve focal kinking of the cannula, cannulae compression involve a much larger segment of the cannula.If the reduced flow results in high circuit pressure alarms during use and if not able to be corrected by the surgical team, this could result in permanent injury.This could require a temporary interruption of cpb.Since the patient¿s blood flow is dependent on cpb during this portion of the procedure the risk of injury is not remote.In this case, there were no discernible clinical consequences for the patient, no blood loss occurred.The patient was hospitalized in stable conditions.The root cause of the event remains indeterminable.If new information becomes available, a supplemental report will be reported.

Event Description

Edwards received notification that during a cardiac case, the tip of a single stage venous cannula got twisted and kinked resulting in restricted blood flow (due to a short "air lock" on hlm).The device was used as per instructions of use.Packaging was ok.Access vessel was vena cava superior in open surgery.It was a normal vessel at the point of insertion (normal anatomy, no calcification).The twisting was noticed on hlm after approximately one hour.Manipulation to correct the twist in the cannula resulted in air entering the cannula with a stop of the blood flow through the cannula as a results of an "air lock".There were no discernible clinical consequences for the patient, no blood loss occurred.The patient was hospitalized in stable conditions.

Manufacturer Narrative

Additional manufacturer narrative: edwards received additional information through follow up with the healthcare provider.An engineering evaluation was performed and a manufacturing, supplier, design, ifu, and labeling defect were not confirmed.Capa/pra action are not required.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.Root cause cannot be determined at this time.

Event Description

Edwards received additional information through follow up with the healthcare provider.Edwards received notification that during a cardiac case, the tip of a single stage venous cannula got twisted and kinked resulting in restricted blood flow (due to a short "air lock" on hlm).Packaging was ok.The device was used as per instructions of use.Access vessel was vena cava superior in open surgery.It was a normal vessel at the point of insertion (normal anatomy, no calcification).Cannula was secured in placed with an stitch + tourniquet.A snare was use to keep the cannula in placed but not tightened.The twisting was noticed on hlm after approx.1 hour.Manipulation to correct the twist in the cannula resulted in air entering the cannula with a stop of the blood flow through the cannula as a results of an "air lock".There were no discernible clinical consequences for the patient, no blood loss occurred.The patient was hospitalized in stable conditions.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: VENOUS RETURN CANNULA OPEN TIP
• Type of Device: VENOUS CANNULAE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8676673
• MDR Text Key: 148016518
• Report Number: 3008500478-2019-00139
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TF024O90
• Device Catalogue Number: TF024O90
• Device Lot Number: 61492164
• 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 Age: 30 YR
• Patient Weight: 58