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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 Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2021
Event Type  malfunction  
Manufacturer Narrative
Leaks in devices with high flow, such as arterial or venous cannulae, will most likely require an exchange of the device. This will require a temporary interruption of cpb. Since the patient's blood flow is dependent on cpb during this portion of the procedure the risk of injury is not remote. The subject devices involved in this complaint were not saved after use and are unavailable to be returned for evaluation. 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. If new information becomes available, a supplemental report will be submitted.
 
Event Description
It was reported that five (5) opti18 optisite arterial perfusion devices had leaked out from the back on five (5) distinct cases. There were no reports of patient issues or injuries. Per additional information received, the leaks were coming from the red cap on the obturator when cannulating. There was no compromise to the packaging and the cannulae are stored in a long plastic bin alongside others in parallel. The leaks were reportedly occurring for bypass cases. Once connected to the bypass circuit there are no problems. No samples were saved to be returned.
 
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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
gail warner
1 edwards way
irvine, CA 92614
9492504096
MDR Report Key12302999
MDR Text Key265883641
Report Number2015691-2021-04608
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
Type of Report Initial,Followup
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOPTI18
Device Catalogue NumberOPTI18
Device Lot Number63561570
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/10/2021 Patient Sequence Number: 1
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