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 2019-06-19 for WAVELINQ ENDOAVF SYSTEM FX-001CE manufactured by Tva Medical, Inc..
| Report Number | 3011392541-2019-00008 |
| MDR Report Key | 8713001 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-06-19 |
| Date of Report | 2019-06-19 |
| Date of Event | 2019-05-23 |
| Date Mfgr Received | 2019-05-23 |
| Date Added to Maude | 2019-06-19 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | TVA MEDICAL, INC. |
| Manufacturer Street | 7000 BEE CAVE ROAD SUITE 250 |
| Manufacturer City | AUSTIN TX 78746 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78746 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAVELINQ ENDOAVF SYSTEM |
| Generic Name | ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE |
| Product Code | PQK |
| Date Received | 2019-06-19 |
| Returned To Mfg | 2019-06-07 |
| Model Number | FX-001CE |
| Catalog Number | FX-001CE |
| Lot Number | S0051 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TVA MEDICAL, INC. |
| Manufacturer Address | 7000 BEE CAVE ROAD SUITE 250 AUSTIN TX 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-19 |