MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC OPTISITE ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number OPTI20

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation.Attempts to retrieve additional information and device is in process.If additional information is received a supplemental mdr will be submitted.Kinking implies a focal, reversible narrowing of the lumen which may have many root causes.Significant kinks will be identified prior to use, at which time the cannula can be exchanged for another.Smaller kinks that occur during the procedure may be due to anatomic anomalies and not the device.The cause of the event cannot be determined.

Event Description

Edwards received notification that during use this 20fr cannula was observed to be kinked.As reported, the kink would prevent the establishment of the full required blood flow at the start of cardiopulmonary bypass.The perfusionist was not able to reach the calculated flow as bypass was initiated due to high pressure in the circuit.Bypass was terminated to investigate and change the cannula to a larger size.As the cannula was removed, the surgeon discovered the cannula was kinked.The cannula was changed, bypass was re-started with a different brand of cannula.There was no harm to the patient.Reportedly, the cannula had been stored at hospital for approximately one month.The medical team did not observed any deficiency in the packaging to in the cannula prior use.The device was kept in order to be able to return for investigation.Of note, it was commented that the original kinked area would be unfortunately hard to identify as the surgeon and surgical assistant reproduced the further kinks along the cannula to evaluate how much pressure would cause a distortion.The surgeon communicated that the wire wound section was very soft and easy to distort.

Manufacturer Narrative

H10.Additional manufacturer narrative: added h6 investigation, findings, and conclusion codes.Visual inspections are performed at edwards on opti20 devices during receipt, assembly, and packaging, at which point a damaged cannula would have been detected.Although a definitive root cause could not be conclusively determined, the cannula may have been damaged during shipment, storage, or preparation.Based on the information available, an edwards/supplier defect has not been confirmed.

Manufacturer Narrative

Device evaluation: customer complaint of optisite cannula was observed to be kinked was confirmed.As received, introducer was inserted into the cannula.Cannula was observed to have several kinks along entire cannula body.Introducer was removed from the cannula with difficulty and met resistance when pushed through the.The device history record 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.Complaint was confirmed via evaluation.The cause of the event cannot be determined at this time.

• Brand Name: OPTISITE ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 11801025
• MDR Text Key: 252341499
• Report Number: 2015691-2021-02899
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K073559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2023
• Device Model Number: OPTI20
• Device Lot Number: 63211867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1