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

Model Number OPTI22

Device Problem Material Deformation (2976)

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

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narratives: cannulae that compress or collapse during use, may impede blood flow during cardiopulmonary bypass (cpb).Unlike issues that involve focal kinking of the cannula, compression involves a much larger segment of the cannula and could result in an interruption of bypass.The device is being returned for evaluation.If new information becomes available, a supplemental report will be submitted.

Event Description

Edwards received notification that the body of this cannula was observed damaged when trying to move the suture ring along the body shaft.As reported, the cannula body collapses in specific areas such as suture ring.No issue was noted when opening the packaging.The packaging did not have any visible damage.The cannula was not clamped.The cannula was storage at hospital less than 30 days.No incidents with patient were reported.

Event Description

Edwards received notification that the body of this cannula was damage when trying to move the suture ring along the body shaft.As reported, the cannula body collapses in the area of the suture ring.The issue was not noted when opening the package.The incident occurred before flushing; the or technician did not flush or irrigate the cannula before moving the suture ring along the shaft.The external packaging did not have any visible damage.The cannula was not clamped.The cannula was stored at hospital less than 30 days.No incidents with patient were reported.

Manufacturer Narrative

H10: additional narratives updated h6 per new information received.

Manufacturer Narrative

H10: additional narratives.Updated d4, h4, and h6 per new information received.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.

Manufacturer Narrative

Three images were provided.The images showed a kinked model opti20 cannula, introducer inserted into the opti22 cannula, and pouch from reported model opti22 with lot/serial number.Report of damage on the opti22 cannula was confirmed through image evaluation.The cannula appears to have multiple indentations along the wire reinforced section of the cannula body.

• Brand Name: EDWARDS LIFESCIENCES OPTISITE ARTERIAL PERFUSION CANNULA
• Type of Device: CANNULA, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: gail warner ; one edwards way; mailstop 6.1 anton; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12100285
• MDR Text Key: 260351860
• Report Number: 2015691-2021-03875
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: OPTI22
• Device Catalogue Number: OPTI22
• Device Lot Number: 63257601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2021
• Date Device Manufactured: 07/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1