MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for SWAN-GANZ VIP+ 834F75 manufactured by Edwards Lifesciences Llc.
[178574302]
Nurse in cardiovascular intensive care unit (cvicu) attempted to pull swan ganz catheter at order of nurse practitioner. The nurse met resistance and stopped pulling catheter, replaced dressing, and notified nurse practitioner. The physician was notified. A chest x-ray was performed. The patient was taken back to operating room for fragment to be removed. The physician located the fragment at juncture of superior vena cava and right atrium. Fragment removed without difficulty. Patient returned to cvicu post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9693290 |
| MDR Report Key | 9693290 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-01-31 |
| Report Date | 2020-02-06 |
| Date Reported to FDA | 2020-02-06 |
| Date Reported to Mfgr | 2020-02-11 |
| Date Added to Maude | 2020-02-11 |
| 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 VIP+ |
| Generic Name | CATHETER, FLOW DIRECTED |
| Product Code | DYG |
| Date Received | 2020-02-11 |
| Model Number | 834F75 |
| Catalog Number | 834F75 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| 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 | 1. Other; 2. Required No Informationntervention | 2020-02-11 |