MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for SWAN-GANZ D97130F5 manufactured by Edwards Lifesciences Llc.
[177370535]
Pacing catheter did not capture. Prior to exchanging device from body, the box and pacer wires were changed. Then after this was exchanged with new catheter and able to continue with case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9659298 |
| MDR Report Key | 9659298 |
| Date Received | 2020-02-03 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-12-18 |
| Report Date | 2019-12-19 |
| Date Reported to FDA | 2019-12-19 |
| Date Reported to Mfgr | 2020-02-03 |
| Date Added to Maude | 2020-02-03 |
| 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 |
| Generic Name | CATHETER, FLOW DIRECTED |
| Product Code | DYG |
| Date Received | 2020-02-03 |
| Model Number | D97130F5 |
| Catalog Number | D97130F5 |
| Lot Number | 62290514 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 0 YR |
| 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 | 2020-02-03 |