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.
[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
| Report Number | 3008500478-2020-00186 |
| MDR Report Key | 9656203 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-01 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-01-07 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2020-02-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. AMRITHA SRINIVASAN |
| Manufacturer Street | 1 EDWARDS WAY MLE-2 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492504062 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZ GLIDE AORTIC CANNULA |
| Generic Name | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Product Code | DWF |
| Date Received | 2020-02-01 |
| Returned To Mfg | 2020-01-23 |
| Model Number | EZC21TA |
| Catalog Number | EZC21TA |
| Device Expiration Date | 2013-12-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | 1 EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-01 |