MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-04 for SKATER INTRODUCER SYSTEM 651506300 manufactured by Argon Medical Devices.
[182297553]
The sample device is indicated as available for return. Customer has notified argon that sample cannot be returned until sometime later in february. A follow-up report with additional information will be provided by 3/6/2020.
Patient Sequence No: 1, Text Type: N, H10
[182297574]
After placement of a drainage catheter, and took a picture under fluoroscopy to checked the placement of the tube, and found the distal coil of the 0. 018? Guidewire was stripped off the core in the vivo. Hence the doctor need to do another procedure to took the coil out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2020-00112 |
| MDR Report Key | 9667316 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-13 |
| Date of Event | 2020-01-06 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-04 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKATER INTRODUCER SYSTEM |
| Generic Name | SKATER INTRODUCER |
| Product Code | GCB |
| Date Received | 2020-02-04 |
| Catalog Number | 651506300 |
| Lot Number | 11267865 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES |
| Manufacturer Address | 1445 FLAT CREEK RD ATHENS TX 75751 US 75751 |
| Brand Name | ACETAMINOPHEN 500MG |
| Product Code | --- |
| Date Received | 2020-02-04 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURE / COMPOUNDER NAME |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-04 |