MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-16 for SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION PE074F5 manufactured by Edwards Lifesciences, Pr.
[188654785]
The device evaluation is in progress. A supplemental report will be sent with the investigation results. A device history record review was completed and documented that device met all specifications upon distribution.
Patient Sequence No: 1, Text Type: N, H10
[188654786]
It was reported that the swan ganz catheter was unable to pace from the beginning of use. The catheter was replaced and the problem was solved. It is unknown if the patient had cardiac conduction defect. Patient demographic information requested but unavailable. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10206 |
| MDR Report Key | 9596891 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-16 |
| Date of Report | 2019-12-25 |
| Date of Event | 2019-12-25 |
| Date Mfgr Received | 2019-12-25 |
| Device Manufacturer Date | 2019-08-05 |
| Date Added to Maude | 2020-01-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. SAMANTHA EVELEIGH |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| Manufacturer G1 | EDWARDS LIFESCIENCES, PR |
| Manufacturer Street | STATE RD INDUS PK 402 KM 1.4 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION |
| Generic Name | PACING CATHETER |
| Product Code | LDF |
| Date Received | 2020-01-16 |
| Returned To Mfg | 2020-01-14 |
| Model Number | PE074F5 |
| Lot Number | 62451089 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES, PR |
| Manufacturer Address | STATE RD INDUS PK 402 KM 1.4 ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |