MAUDE Adverse Event Report: EDWARDS LIFESCIENCES OPTISITE ARTERIAL CANNULA; CANNULA, CATHETER

Model Number	OPTI16
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11 additional manufacturer narrative (including h3 findings thus far): the device was returned for evaluation.Customer report of deformed wire was confirmed and exposed wire was found.A preliminary device history review was performed and no rework, deviations, or nonconformances were found to be associated with the respective work order.Per initial product evaluation, the customer report of wire deformation was confirmed.As received, one opti16 cannula with opened pouch packaging.Device was returned with visible traces of blood.Wire at the distal end of the cannula at the wire reinforcement section was bunched up together.In addition, a 1mm section of wire from the wire reinforcement of the cannula was found to be exposed from the cannula body 16mm from distal tip.Wire appeared to match the length of the groove.No other visual damage, contamination, or other abnormalities were found to the cannula or the introducer.Photo provided prior to evaluation was consistent with lab findings.The reported event is pending further investigation.A supplemental report will be submitted in a timely manner once the investigation has been completed or new information becomes available.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Event or Problem Description
It was reported that deformation of the wire of an opti16 arterial perfusion cannula was observed at the proximal end before use.The issue was found just before inserting the cannula into the patient after opening the pouch.The device was exchanged with another opti16 cannula and was never used on the patient.No patient adverse event was reported.Per the reported information, this event occurred in a pediatric cardiovascular surgery case.There were no damages observed on the shelf box or the outer box.The pouch was completely sealed before opening.The device was stored horizontally on the shelf in the hospital storage with the room temperature kept around 20 degrees celsius.The device was returned for evaluation.The device was returned with a tube attaching near the wire deformation site as a marker.A photo of the wire deformation was taken by the sales rep.
Additional Manufacturer Narrative
G3/ g6/ h2/ h3 updated h6 investigation type/ findings/ conclusions updated.H11/ h3: the following are findings from additional evaluation and investigation.Per dhr review, no rework, deviation, or nc was found to be associated with this lot number.The supplier also confirmed the wires are bunched as stated in the original complaint [but] would pass [specification] regarding bunched wires for overlap/cross wire [.] regarding the exposed wire, the root cause is unknown.It appears material has been removed from in front of the wire causing the face and some of the top of the wire to become exposed.It is possible but unlikely this is manufacturing related.Based on the available information, the complaint of bunched wire has been confirmed, but has been found to be an acceptable cosmetic issue.A supplier nonconformance was not confirmed.In regards to the exposed wire observed, it is suspected that physical damage may have removed material from the body of the cannula.As there was a tactile assessment performed with a metal object during returned product evaluation, it is indeterminable whether the damage occurred during manufacturing or may have been caused during evaluation.No evidence of an internal edwards defect has been found.Edwards will continue to review and monitor all reported 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: CANNULA, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: dannette crooms ; 1 edwards way; irvine, CA 92614 ; 8018424930
• MDR Report Key: 22101658
• Report Number: 2015691-2025-04218
• Device Sequence Number: 20671618
• Product Code: DQR
• UDI-Device Identifier: 00690103180558
• UDI-Public: (01)00690103180558(17)260427(11)230427(10)BSLC1682
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2026
• Device Model Number: OPTI16
• Device Lot Number: BSLC1682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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
• Patient Sex: Unknown