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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES OPTISITE ARTERIAL CANNULA CANNULA, CATHETER Back to Search Results
Model Number OPTI18
Device Problems Insufficient Information (3190); Separation Problem (4043)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
These cannulae are used to divert large volumes of blood between the patient circulation and the cardiopulmonary bypass machine during cardiac surgery and, on occasion, ecmo (off-label use). This malfunction/defect would likely require an exchange of the cannula resulting in a temporary interruption of bypass and possibly significant blood loss. The potential for serious injury before or during use is not remote. In this case, the connector of this arterial perfusion cannula was disconnecting from the tubing. The subject device was returned for evaluation. Upon compilation of the product evaluation, a supplemental report with findings will be submitted. A root cause of this event cannot be conclusively determined with the provided information. 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 Description
It was reported that the connector of an opti18 arterial perfusion cannula was disconnecting from the tubing. There were no adverse events to the patient. No defects were noted on the opti18 device upon opening. Per received additional information, the disconnection was observed between the catheter connector and catheter during cannulation. The device was placed in the ascending aorta. The issue was resolved by placing a connector directly into the aortic cannula.
 
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Brand NameOPTISITE ARTERIAL CANNULA
Type of DeviceCANNULA, CATHETER
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer Contact
amritha srinivasan
1 edwards way
irvine, CA 92614
9492504062
MDR Report Key11645423
MDR Text Key244878772
Report Number2015691-2021-02377
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOPTI18
Device Catalogue NumberOPTI18
Device Lot Number63426501
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/09/2021 Patient Sequence Number: 1
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