MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-14 for ATRIEVE VASCULAR SNARE 382006010 manufactured by Argon Medical Devices Inc..
[133189925]
The review the device history record and inspection record and no similar concerns were found. A review of the returned product was performed. Visual inspection noted that the radiopaque (marker band) was missing from the delivery catheter, and the complaint was confirmed. The delivery catheter is purchased from a supplier. The supplier has been notified of the issue and a follow-up report will be provided when the supplier provides a root cause and corrective action.
Patient Sequence No: 1, Text Type: N, H10
[133189926]
Atrieve vascular snare kit was inserted into the 6fr destination guiding sheath and pull in the 0. 014 inch guidewire successfully. During procedure, through the angiography image, the physician found that the radiopaque band on the atrieve kit catheter was left on the patient? S left deep artery of thigh. The physician tried to remove the radiopaque band using balloon catheter, but it failed. The physician elected to let the radiopaque band remain in the patient's body and complete the procedure. No health damage has been reported with this case at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2018-00211 |
| MDR Report Key | 8244488 |
| Date Received | 2019-01-14 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-12-07 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2005-01-14 |
| Device Manufacturer Date | 2016-11-30 |
| Date Added to Maude | 2019-01-14 |
| 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 | MS. GAIL SMITH |
| Manufacturer Street | 1445 FLAT CREEK ROAD |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal | 75751 |
| Manufacturer Phone | 2144368995 |
| Manufacturer G1 | ARGON MEDICAL DEVICES INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ATRIEVE VASCULAR SNARE |
| Generic Name | VASCULAR SNARE |
| Product Code | MMX |
| Date Received | 2019-01-14 |
| Returned To Mfg | 2018-12-26 |
| Catalog Number | 382006010 |
| Lot Number | 11158631 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-14 |