MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-02-26 for WAVELINQ ENDOAVF SYSTEM UNK WAVELINQ manufactured by Bard Peripheral Vascular, Inc..
[181199242]
As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. Journal article citation: inston, n. , khawaja, a. , tullett, k. , & jones, r. (2020). Wavelinq created arteriovenous fistulas versus surgical radiocephalic arteriovenous fistulas? A single-centre observational study. The journal of vascular access, 112972981989716. Doi: 10. 1177/1129729819897168.
Patient Sequence No: 1, Text Type: N, H10
[181199243]
It was reported in an article from the journal of vascular access titled " wavelinq created arteriovenous fistulas versus surgical radiocephalic arteriovenous fistulas? A single-centre observational study " that endovascular arteriovenous fistula (w) data was compared with radiocephalic arteriovenous fistula (rc) data prospectively. Failure in the first year was higher in rc arteriovenous fistulas (avf) than in wavelinq endoavf (42. 5% vs 30. 5%). Intervention per patient year were calculated with 0. 402 in group w and 0. 273 in group rc. In w group, failure (abandoned for other access over the study period) was identified in 8 patients, interventions were (angio/venoplasty in 6 patients, stent placement in 1 patient, secondary coiled embolization in 4 patients, transposition/revision in 6 patients, and thrombolysis in 1 patient) required. The status of the patients was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-01132 |
| MDR Report Key | 9758347 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-26 |
| 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 | 1415 W. 3RD STREET |
| 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 | 2020-02-26 |
| Catalog Number | UNK WAVELINQ |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-26 |