MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-13 for WAVELINQ 4 FR W04200 manufactured by Bard Peripheral Vascular, Inc..
[179400312]
The lot number for the device was provided. The device history records are currently under review. The device has been returned for evaluation. The investigation is currently underway. (expiry date: 09/2021).
Patient Sequence No: 1, Text Type: N, H10
[179400313]
It was reported that during the arteriovenous fistula creation procedure, the electrode of the venous catheter was identified allegedly deformed (misshaped) under fluoroscopy prior to activation; therefore, the venous catheter was not activated and removed from the patient without incident. Reportedly, another venous catheter was used to complete the procedure. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-01008 |
| MDR Report Key | 9708398 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-02-13 |
| 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 | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAVELINQ 4 FR |
| Generic Name | ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE |
| Product Code | PQK |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-01-29 |
| Model Number | W04200 |
| Catalog Number | W04200 |
| Lot Number | S0081 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-13 |