MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-06 for WAVELINQ ENDOAVF SYSTEM WQ4300 manufactured by Bard Peripheral Vascular, Inc..
[180521669]
The lot number for the device was provided. The device history records are currently under review. The device is pending return. The investigation is currently underway.
Patient Sequence No: 1, Text Type: N, H10
[180521670]
It was reported that during an attempt to create the ulnar-ulnar arteriovenous fistula (avf) in the left arm through a brachial artery and vein access, the catheters were advance without issue but were unable to proximal the end of the catheters; the magnets that coapt advanced further distal beyond the proper ulnar vein and artery. It was further reported that the catheters did come together but when brought them back to the field of creation, the proximal magnets were allegedly too far apart and unable to create the fistula. Therefore, the catheter were removed through the introducer sheaths without issue from the patient. A surgical fistula will be scheduled for a future date. The was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2019-05906 |
| MDR Report Key | 9555256 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-06 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-11-20 |
| Date Added to Maude | 2020-01-06 |
| 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 ENDOAVF SYSTEM |
| Generic Name | ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE |
| Product Code | PQK |
| Date Received | 2020-01-06 |
| Returned To Mfg | 2020-01-07 |
| Model Number | WQ4300 |
| Catalog Number | WQ4300 |
| Lot Number | S0091 |
| 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 | 2020-01-06 |