MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-29 for WAVELINQ ENDOAVF SYSTEM FX-001CE manufactured by Tva Medical, Inc..
[143560984]
As a result of the acquisition of tva medical, inc. , on (b)(6) 2018 a retrospective review was completed on (b)(6) 2018. Based on (b)(4) internal procedures and 21 cfr part 803 regulation this event is classified as an mdr reportable event.
Patient Sequence No: 1, Text Type: N, H10
[143560985]
It was reported that upon activation of the devices in the ulnar artery and vein, the electrode allegedly failed to cut the tissue. Reportedly, no fistula was formed, and no further attempts were made to create the arteriovenous fistula (avf). There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011392541-2019-00006 |
| MDR Report Key | 8563136 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-29 |
| Date of Event | 2018-08-23 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2019-04-29 |
| 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 | 2019-04-29 |
| Model Number | FX-001CE |
| Catalog Number | FX-001CE |
| Lot Number | S0036 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-29 |