MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-19 for CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM 7F X 65CM 700015 manufactured by Argon Medical Devices Inc..
[183733562]
The sample device is indicated as unavailable for evaluation. Without the device or any visual evidence of the product issue, the complaint cannot be confirmed and a root cause cannot be concluded. If additional information is provided in the future, the investigation will be re-opened as needed.
Patient Sequence No: 1, Text Type: N, H10
[183733563]
Doctor was advancing the cleaner the tip came off and they had to retrieve with a snare. Doctor has done many filter cases and not sure what he did differently for this to happen. Dr bools
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2020-00173 |
| MDR Report Key | 9729779 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-19 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-31 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-19 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM 7F X 65CM |
| Generic Name | CLEANER |
| Product Code | KRA |
| Date Received | 2020-02-19 |
| Catalog Number | 700015 |
| Lot Number | REF170026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-19 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURE / COMPOUNDER NAME |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-19 |