MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for EDWADS SWAN GANZ CATHETER PULMONARY ARTERY CATHTER C146FZ manufactured by Edwards Lifesciences,l Llc..
[174670496]
Swan ganz catheter balloon had a slow leak allowing air to escape into the patient? S bloodstream. This product is latex free and the balloons are very friable. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092132 |
| MDR Report Key | 9569757 |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-07 |
| Date of Event | 2020-01-03 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDWADS SWAN GANZ CATHETER PULMONARY ARTERY CATHTER |
| Generic Name | CATHETER, FLOW DIRECTED |
| Product Code | DYG |
| Date Received | 2020-01-08 |
| Model Number | C146FZ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES,L LLC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |