MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-22 for ATRIEVE VASCULAR SNARE 381003004 manufactured by Argon Medical Devices Inc..
[93690582]
There were no samples or images available for review and a lot number was not provided. Without the sample to review, a definite root cause and corrective action cannot be established. Since a lot number was not provided, a review of the device history record and inspection records could not be conducted. This product is not intended for use in the brain, but is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects.
Patient Sequence No: 1, Text Type: N, H10
[93690583]
The doctor was using the atrieve snare in the brain the radiopaque band fell off and remained in brain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2017-00154 |
| MDR Report Key | 7054750 |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-10-26 |
| Date Mfgr Received | 2017-10-27 |
| Date Added to Maude | 2017-11-22 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | 2017-11-22 |
| Catalog Number | 381003004 |
| Lot Number | UNK |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2017-11-22 |