MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-14 for LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET LR-EVN-13.0-RL manufactured by Cook Vandergrift Inc.
| Report Number | 2522007-2019-00022 |
| MDR Report Key | 9324243 |
| Date Received | 2019-11-14 |
| Date of Report | 2019-11-14 |
| Date of Event | 2019-09-10 |
| Date Mfgr Received | 2019-10-16 |
| Date Added to Maude | 2019-11-14 |
| 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 | MR. BRIAN JOHNSTON |
| Manufacturer Street | 1186 MONTGOMERY LANE |
| Manufacturer City | VANDERGRIFT PA 15690 |
| Manufacturer Country | US |
| Manufacturer Postal | 15690 |
| Manufacturer Phone | 7248458621 |
| Manufacturer G1 | COOK VANDERGRIFT INC |
| Manufacturer Street | 1186 MONTGOMERY LANE |
| Manufacturer City | VANDERGRIFT PA 15690 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15690 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET |
| Generic Name | VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION |
| Product Code | DRE |
| Date Received | 2019-11-14 |
| Catalog Number | LR-EVN-13.0-RL |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK VANDERGRIFT INC |
| Manufacturer Address | 1186 MONTGOMERY LANE VANDERGRIFT PA 15690 US 15690 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-14 |