MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-13 for SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH 545-511 manufactured by The Spectranetics Corporation.
| Report Number | 1721279-2019-00194 |
| MDR Report Key | 9316231 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-13 |
| Date of Report | 2019-10-19 |
| Date of Event | 2019-10-19 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-10-19 |
| Device Manufacturer Date | 2019-01-04 |
| Date Added to Maude | 2019-11-13 |
| 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 | MRS. BARBARA CREEL |
| Manufacturer Street | 9965 FEDERAL DRIVE |
| Manufacturer City | COLORADO SPRINGS CO 80921 |
| Manufacturer Country | US |
| Manufacturer Postal | 80921 |
| Manufacturer Phone | 719447-246 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH |
| Generic Name | TIGHTRAIL |
| Product Code | DRE |
| Date Received | 2019-11-13 |
| Model Number | 545-511 |
| Catalog Number | 545-511 |
| Lot Number | FRK19A04A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE SPECTRANETICS CORPORATION |
| Manufacturer Address | 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2019-11-13 |