MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-17 for EDWARDS LIFESCIENCES FEM-FLEX II ARTERIAL AND FEMORAL CANNULAE FEMII020A manufactured by Edwards Lifesciences.
[176845468]
The device was returned to edwards for evaluation as is pending evaluation. Udi number: (b)(4). The cause of the event cannot be determined at this time. A supplemental mdr will be submitted as new information is received. 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.
Patient Sequence No: 1, Text Type: N, H10
[176845469]
Edwards received information a 20 fr arterial catheter had split. Patient was on vv emco, through the groin and ij, upon initiation, a large amount of blood was pouring from neck. The cannula split shortly after initiation. "it is our belief the cannula did not split during cannulation. " the cannula was reported to be cracked near one of the barbs on the distal part of the shaft in between the barbs. The patient became hypotensive. At the time the surgeon had thought he had perforated the carotid. They quickly changed to femoral arterial va ecmo to control the bleeding and support the patient. Upon investigation on the neck, it was found that the blood was pouring out og the 20 fr arterial catheter in the neck, it had split. Cannula was saved. Copious amount of blood was and emergency transfusion protocol was initiated. Patient was transfused with two units of blood and 2 ffp. Patient was initially put on ecmo for a respiratory issue, once the cannula cracked patient was switched to va ecmo in the groin. Patient was taken to hybrid room to insert a distal perfusion cannula. It was decided to convert patient back to vv. Patient in or receiving support. Patient is still on ecmo in icu in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008500478-2020-00183 |
| MDR Report Key | 9603685 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-17 |
| Date of Report | 2019-12-24 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2019-12-24 |
| Device Manufacturer Date | 2019-03-26 |
| Date Added to Maude | 2020-01-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. AMRITHA SRINIVASAN |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492504062 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDWARDS LIFESCIENCES FEM-FLEX II ARTERIAL AND FEMORAL CANNULAE |
| Generic Name | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Product Code | DWF |
| Date Received | 2020-01-17 |
| Returned To Mfg | 2020-01-10 |
| Model Number | FEMII020A |
| Catalog Number | FEMII020A |
| Lot Number | 61997891 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2020-01-17 |