MAUDE Adverse Event Report: EDWARDS LIFESCIENCES OPTISITE ARTERIAL CANNULA

Model Number	OPTI18
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 kinking may result in a cannula exchange that disrupts cardiopulmonary bypass.The device was not returned for evaluation, as the device request is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Event or Problem Description
It was reported that an arterial cannula got kinked during procedure.Another cannula was used.There was no patient injury.As reported, nothing unusual happened during cannulation process.The cannula was secured, which puts it at somewhat of a bend.The surgical team went on bypass and noticed high line pressures.Cannula was checked and kinking was observed where the main cannula tubing meets the thicker tubing.The surgeon was not able to pinch cannula to relieve the kinking.A new device had to be used.It was believed that for some reason, the cannula is not as robust at that point as it used to be, and it is kinked when it is secured in a curved fashion.The surgeon is extremely skilled and has been doing surgery for 25 years.His technique is identical every time.He has used this same cannula for at least 7 years with no issues before.
Additional Manufacturer Narrative
H3: product evaluation.Customer complaint of kinked optisite cannula was confirmed.As received, cannula was observed to have two kinks along the cannula body approximately 3.8" and 6" from the distal end.No other visual damage, contamination, or other abnormalities were found to the cannula.
Additional Manufacturer Narrative
The root cause of this event cannot be conclusively determined.However, it is likely that procedural factors/customer handling contributed to the event.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.

• Brand Name: OPTISITE ARTERIAL CANNULA
• Common Device Name: ARTERIAL CANNULA
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; one edwards way; mailstop anton 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13668726
• Report Number: 2015691-2022-04259
• Device Sequence Number: 11985447
• Product Code: DQR
• UDI-Device Identifier: 00690103180565
• UDI-Public: (01)00690103180565(17)240323(11)2103242163648641
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K073559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2024
• Device Model Number: OPTI18
• Device Catalogue Number: OPTI18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 04/08/2022; 05/10/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 05/04/2022; 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown