MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for SWAN-GANZ COMBO 746F8 manufactured by Edwards Lifesciences Llc.
[183519024]
Elderly patient with history of severe aortic stenosis undergoing a coronary artery bypass graft x 2 with aortic valve replacement. When the edwards lifescience swan-gantz was checked prior to usage, there was no balloon on the swan-gantz device. The device was not used on the patient, no harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9834734 |
| MDR Report Key | 9834734 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-05 |
| Report Date | 2020-03-06 |
| Date Reported to FDA | 2020-03-06 |
| Date Reported to Mfgr | 2020-03-16 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWAN-GANZ COMBO |
| Generic Name | CATHETER, FLOW DIRECTED |
| Product Code | DYG |
| Date Received | 2020-03-16 |
| Model Number | 746F8 |
| Catalog Number | 746F8 |
| Lot Number | 62685955 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES LLC |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |