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

Model Number OPTI20

Device Problems Inadequacy of Device Shape and/or Size (1583); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2020

Event Type  Injury  

Manufacturer Narrative

Out of box failures can result from many different product malfunctions, some less serious than others.If the malfunction occurring out of box would have been reportable had it occurred in the patient, then it should be reportable.This should be based on the actual failure mode or non-conformance.In this case, it was reported that the introducer of an optisite cannula was observed to be much longer than usual before use.The patient was not involved.However, the clinician was concerned that the longer length of the introducer could have resulted in cannulation through the back wall of the aorta.The potential for injury is not remote.The device has not been returned for evaluation at this time.The root cause of this event cannot be conclusively determined.If new information becomes available, a supplemental report will be submitted.

Event Description

Edwards received notification that the introducer of this cannula was observed to be much longer than usual.This was noticed prior to use.As reported the reporter was concerned because this longer length could have allowed them to cannulate through the back wall of the aorta.

Manufacturer Narrative

Customer complaint of "longer than usual" introducer was not confirmed with assessment.As received, the red cap was past the second barb of connector with introducer not fully engaged in cannula. the introducer was passed through returned cannula with no resistance.Length measurement of the introducer tip to introducer shaft marking was taken.The introducer shaft marking to introducer tip was measured at 2.12".The length measurement of the marking to distal tip is within specification (2.12 +0.05"/-0.15") as listed in drawing.Length measurement of introducer tip to white introducer hub was also taken.The white introducer hub to introducer tip was measured at 10.55".The length measurement of the white introducer hub to distal tip is within specification (10.55 ± 0.05¿) as listed in drawing.No other visual damage, contamination, or other abnormalities were found to the device.Engineering evaluation has been opened and assigned for further investigation.Photos attached by complaint handler appeared consistent with lab findings.

Event Description

Edwards received notification that the introducer of this cannula was observed to be much longer than usual.This was noticed prior to use.As reported cannulation site was central cannulation (aorta) and no guidewire is used.The customer considered the possibility that the cannula may have actually been pushed too far (i.E.When pushing the red cap on, if pushed too hard the introducer can be longer that it should be) and was wondering if this should occur.The customer was concerned because this longer length could have allowed them to cannulate through the back wall of the aorta.

Manufacturer Narrative

It was reported that the introducer of an opposite cannula was observed to be much longer than usual before use.There was no patient involved.However, the clinician was concerned that the longer length of the introducer could have resulted in cannulation through the back wall of the aorta.Per product evaluation, it was confirmed that the dimensions of the introducer were within the manufacturing specifications with no other device deficiencies observed.No death or serious injury; potential for injury is remote.

Manufacturer Narrative

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

H11.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: OPTISITE ARTERIAL PERFUSION CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9993226
• MDR Text Key: 188811380
• Report Number: 3008500478-2020-00195
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OPTI20
• Device Lot Number: 62769072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention