MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for SWAN-GANZ D97130F5 manufactured by Edwards Lifesciences Llc.
[182539401]
When placing of pacemaker, the patient had temporary wires in, md then placed the pacer. When pulling back, the piece at the hub became disconnected. The end of the transvenous pacer broke off inside the sheath cover hub. The md fluoro(ed) the patient and there was no harm or retained foreign body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9804998 |
| MDR Report Key | 9804998 |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-27 |
| Date of Event | 2019-11-18 |
| Report Date | 2020-02-27 |
| Date Reported to FDA | 2020-02-27 |
| Date Reported to Mfgr | 2020-03-09 |
| Date Added to Maude | 2020-03-09 |
| 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 |
| 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 |
| Generic Name | CATHETER, FLOW DIRECTED |
| Product Code | DYG |
| Date Received | 2020-03-09 |
| Model Number | D97130F5 |
| Catalog Number | D97130F5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-09 |