MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,08 report with the FDA on 2014-05-14 for ASAHI FIELDER GUIDE WIRE AGP140000 manufactured by Asahi Intecc Co., Ltd..
[4498033]
After using to treat another cto lesion at sfa, subject guidewire was used for a cto lesion at bk area. During the procedure, guidewire distal end was trapped in the lesion nearby the ankle, the distal end was broken off and remained in the anatomy. Separated fragment was left in the vessel at the physician's decision. Pt is reportedly going well.
Patient Sequence No: 1, Text Type: D, B5
[11796785]
Investigation of returned guidewire device revealed both core wire and coil were broken at approximately 31mm from tip end. Microscopic close observation revealed that the core wire was broken due to excessive rotational force to counterclockwise direction. Lot history review revealed no anomaly relating to the reported event. No other product experience report was received for this lot. It is inferred distal end of the guidewire was trapped in the cto lesion, where counterclockwise rotational manipulation was consecutively applied, so that the core wire and the coil was broken when the accumulated force exceeded the product design limit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003775027-2014-00030 |
| MDR Report Key | 3824408 |
| Report Source | 00,08 |
| Date Received | 2014-05-14 |
| Date of Report | 2014-04-30 |
| Date of Event | 2014-04-17 |
| Date Mfgr Received | 2014-04-30 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-05-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | EIICHI KUBO |
| Manufacturer Street | 3-100 AKATSUKI-CHO |
| Manufacturer City | SETO, AICHI 489-0071 |
| Manufacturer Country | JA |
| Manufacturer Postal | 489-0071 |
| Manufacturer Phone | 1485551 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASAHI FIELDER GUIDE WIRE |
| Product Code | DOX |
| Date Received | 2014-05-14 |
| Returned To Mfg | 2014-04-30 |
| Model Number | NA |
| Catalog Number | AGP140000 |
| Lot Number | 130808A231 |
| ID Number | NA |
| Device Expiration Date | 2016-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASAHI INTECC CO., LTD. |
| Manufacturer Address | 3-100 AKATSUKI-CHO SETO, AICHI 489-0071 JA 489-0071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2014-05-14 |