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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES OPTISITE ARTERIAL CANNULA

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EDWARDS LIFESCIENCES OPTISITE ARTERIAL CANNULA Back to Search Results
Model Number OPTI20
Device Problems Break (1069); Crack (1135)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not yet been returned to edwards for evaluation. Attempts to retrieve the device and additional information are in process. The device history record (dhr) review could not be performed as the lot number is unknown. A supplemental mdr will be submitted upon receipt of additional information. At this time the cause of the event cannot be determined. There was no patient contact. 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.
 
Event Description
Edwards received information that prior to cannulation of an arterial cannula snapped when inserting the dilator. Device is going to be returned. The tech obtained the two pieces and put the dilator in the cannula when the white connector met the cannula is when the snap occurred.
 
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Brand NameOPTISITE ARTERIAL CANNULA
Type of DeviceARTERIAL CANNULA
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
Manufacturer Contact
amritha srinivasan
one edwards way
irvine, CA 92614
9492504062
MDR Report Key9508743
MDR Text Key207055791
Report Number3008500478-2019-00179
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 health professional,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOPTI20
Device Catalogue NumberOPTI20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/22/2019 Patient Sequence Number: 1
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