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 2020-03-26 for FAST-CATH? TRANSSEPTAL GUIDING INTRODUCER SWARTZ? SL TRANSSEPTAL SERIES, SL1? 8. 406849 manufactured by St. Jude Medical.
| Report Number | 3005334138-2020-00136 |
| MDR Report Key | 9885539 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-06-29 |
| Date Added to Maude | 2020-03-26 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL (AFD-PLYMOUTH) |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FAST-CATH? TRANSSEPTAL GUIDING INTRODUCER SWARTZ? SL TRANSSEPTAL SERIES, SL1? 8. |
| Generic Name | INTRODUCER, CATHETER |
| Product Code | DYB |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-04 |
| Model Number | 406849 |
| Catalog Number | 406849 |
| Lot Number | 7068790 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |