MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-17 for ARGON MEDICAL DEVICES 085210 manufactured by Argon Medical Devices.
[34604710]
Avid medical is the manufacturer of a custom procedure tray that contains a guidewire part # 085210 manufactured by argon medical devices. Avid medical received a complaint on 12/1/2015 originated by (b)(4), value stream leader of ohio state university medical center stating that during procedures they had one guidewire unravel at the tip and three guidewires crimped about 5 inches down the wire. Ms. (b)(4) has been unable to provide a lot #, however one of the complained guidewires was saved and has been shipped to argon medical devices. Avid medical issued formal complaint (b)(4) to the manufacturer argon medical devices stating it was reported during procedures one guidewire unraveled at the tip and three guidewires crimped about 5 inches down the wire - part # 085210, no lot # is available. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1047429-2015-00009 |
| MDR Report Key | 5306917 |
| Date Received | 2015-12-17 |
| Date of Report | 2015-12-17 |
| Date of Event | 2015-12-01 |
| Date Mfgr Received | 2015-12-01 |
| Date Added to Maude | 2015-12-17 |
| 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 | JOY FARBER |
| Manufacturer Street | 9000 WESTMONT DR. |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal | 23168 |
| Manufacturer Phone | 7575663510 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARGON MEDICAL DEVICES |
| Generic Name | GUIDEWIRE |
| Product Code | MOF |
| Date Received | 2015-12-17 |
| Returned To Mfg | 2015-12-16 |
| Model Number | 085210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES |
| Manufacturer Address | 1445 FLAT CREEK RD ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-17 |