MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-04-29 for WAVELINQ ENDOAVF SYSTEM FX-001CE manufactured by Tva Medical, Inc..
[143536130]
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 bdpi internal procedures and 21 cfr part 803 regulation this event is classified as an mdr reportable event. The information provided by bd represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Patient Sequence No: 1, Text Type: N, H10
[143536131]
It was reported that after successfully creating an arteriovenous fistula (avf) in the ulnar artery and vein, the fistula was identified closed during the 0-10 day follow up, and an alleged pseudoaneurysm was also observed. Reportedly, the pseudoaneurysm resolved without requiring any treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011392541-2019-00005 |
| MDR Report Key | 8563095 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-29 |
| Date of Event | 2018-08-20 |
| 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 | S0040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2019-04-29 |