MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-26 for CLEANER XT ROTATIONAL THROMBECTOMY SYSTEM 6F X 135CM 700109XT manufactured by Argon Medical Devices Inc..
[184656533]
The sample device was returned on 2/26/2020. An evaluation of the device is in progress. A follow-up report will be provided by 3/25/2020.
Patient Sequence No: 1, Text Type: N, H10
[184656534]
Gt hold 3 24left brachiocephalic fistula thrombosis. Tpa given to outflow vein and thrombus outflow vein was small in caliber. Opened cleaner device in distal cephalic vein and turned on device. Did not attached to device. Attempted retrieval but vein spasmed and aborted retrieval. Left inappear to spin. Slowly pulled back and tip was no longer patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2020-00191 |
| MDR Report Key | 9758392 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-17 |
| 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 |
| 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 | 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEANER XT ROTATIONAL THROMBECTOMY SYSTEM 6F X 135CM |
| Generic Name | CLEANER |
| Product Code | KRA |
| Date Received | 2020-02-26 |
| Catalog Number | 700109XT |
| Lot Number | REF170029/1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Brand Name | ACETAMINOPHEN 500MG |
| Product Code | --- |
| Date Received | 2020-02-26 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURE / COMPOUNDER NAME |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-26 |