MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for ASAHI SION BLUE 180CM CORONARY GUIDE WIRE AHW14R0045 manufactured by Asahi Intecc Usa, Inc..
[184848789]
The pt underwent coronary catheterization for a complex calcified mid lad lesion. A blue sion wire was used to cross the lesion with difficulty. The diagonal branch was extremely difficult to navigate. A fine cross catheter was used; however, there was difficulty navigating the fine cross around a very tortuous bend. A 1. 0 x 5 mm balloon was used, but the lesion could not be crossed. The fine cross was backed out and a pt wire was used but went subintimal. Next we used a pilot 50 wire without success. A fine cross catheter and the sion blue wire were used again and the vessel was navigated. When attempting to change out the fine cross catheter, the very tip of it snapped off and appeared to adhere to the sion wire. After multiple maneuvers, both the fine cross and scion were removed as a unit, including the tip of the fine cross catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093897 |
| MDR Report Key | 9871639 |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-03 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASAHI SION BLUE 180CM CORONARY GUIDE WIRE |
| Generic Name | WIRE, GUIDE, CATHETER |
| Product Code | DQX |
| Date Received | 2020-03-23 |
| Model Number | AHW14R0045 |
| Lot Number | 191030A03A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASAHI INTECC USA, INC. |
| Manufacturer Address | TUSTIN CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-23 |