EZ GLIDE AORTIC CANNULA EZC21TA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-01 for EZ GLIDE AORTIC CANNULA EZC21TA manufactured by Edwards Lifesciences.

Event Text Entries

[177755124] This device is inserted into the aorta during cardiac surgery. Cracks in the material may lead to loose fragments in the vasculature which could embolize distally and cause infarction. Potential for injury is not remote. The device was not returned for evaluation as it was discarded. The device history record was not able to be reviewed as the lot number was unknown. The root cause of the event remains indeterminable. An engineering evaluation will be performed. Field corrective action ((b)(4)) has been initiated for the ez glide cannula separation issue.
Patient Sequence No: 1, Text Type: N, H10


[177755125] Edwards received information that an ezc21ta cannula split at the tip during use in the aorta. As reported the surgeon was performing surgery with the ezc21ta when it split at the tip and not at the top by the luer lock. There were multiple fractures between the suture hub and wire reinforcement in the hard plastic. The issue was discovered after removal of the cannula once the patient was off bypass and due to extra blood being in the field. Upon inspection after removal all the cracks and hole was noted. There was no harm to the patient for this issue and the surgery was finished. Unfortunately, the staff threw the cannula away. No photos of the cannula are available. This ezc21ta was part of the voluntary recall and the exact lot number was unknown. The voluntary recall cannulas are no longer at the facility so there can be no more use of them.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008500478-2020-00186
MDR Report Key9656203
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-02-01
Date of Report2020-01-07
Date of Event2019-12-27
Date Mfgr Received2020-01-07
Device Manufacturer Date2013-08-01
Date Added to Maude2020-02-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. AMRITHA SRINIVASAN
Manufacturer Street1 EDWARDS WAY MLE-2
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492504062
Manufacturer G1EDWARDS LIFESCIENCES LLC
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal Code92614
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEZ GLIDE AORTIC CANNULA
Generic NameCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Product CodeDWF
Date Received2020-02-01
Returned To Mfg2020-01-23
Model NumberEZC21TA
Catalog NumberEZC21TA
Device Expiration Date2013-12-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES
Manufacturer Address1 EDWARDS WAY IRVINE CA 92614 US 92614


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-01

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