MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-05-14 for ASAHI CHIKAI WAIN-CKI-200 manufactured by Asahi Intecc Co., Ltd..
[108734152]
Manufacturing site: asahi intecc hanoi co. , ltd. Hanoi, vietnam, registration number: (b)(4). Attempts were made to gather thorough event information during complaint processing; no further information could be obtained. When the device was returned to the manufacturer, a reportable malfunction was recognized for the first time; therefore, the date received by the manufacturer was considered the date the device returned. The returned guide wire had its coil wire elongated for approximately 30mm from the middle solder designed to be at 40mm from the wire tip. Under the elongated coil wire, the inner coil wire was exposed. At the proximal side of the elongated coil wire, the fractured core wire was found. The core wire was fractured at approximately 40mm from where elongation of the coil wire originated. At the proximal end of the exposed inner coil wire, trace of the soldering was found. The elongated coil wire remained in one unit; the ball tip remained attached at the distal end of the elongated coil wire. The fractured core wire was microscopically observed. The core wire was found bent proximal to the fracture end. The fracture surface was observed by a scanning electron microscope (sem). The sem image showed dimples and annual ring-like pattern on the flat fracture surface, suggesting the core wire was fractured due to torsional and tensile stress. To observe the distal segment of the core wire fracture, the inner coil wire was removed. The core wire was found fractured at approximately 12mm from the wire tip. Sem observation revealed that the distal fracture was also flat and dimples and annual ring-like pattern were observed on the fracture surface, as seen on the proximal fracture surface. On the core shaft, helical pattern that was made by twisting stress was observed. Although the coil wire was elongated, the coil wire and the inner coil wire remained in one unit. Measuring the length of the core wire, it was concluded that there was no missing part of the core wire, and therefore, the entire guide wire was returned. Lot history review revealed no anomaly relating to the reported event. No other similar product experience report was received for this lot. Based on the obtained information and investigation outcome, it was concluded that the core wire became fractured due to torsional and tensile stress exceeding the product design limit that was applied during wire manipulation when the wire movement was restricted by factors such as vessel tortuosity and/or condition. The coil wire was assumed to get elongated along wire removal from the anatomy. There was no indication of product deficiency. Instructions for use (ifu) sates: (warnings) observe movement of this guide wire in the vessels. Before this guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy. Do not move or torque the guide wire without observing corresponding movement of the tip. Otherwise, the guide wire may be damaged and/or vessel trauma may occur. In addition, ensure that the distal tip of this guide wire and its location in the vessel are visible during manipulations of the guide wire; (warnings) if any resistance is felt due to spasm or the guide wire being bent or trapped while operating the guide wire in the blood vessel or removing it, do not move or torque the guide wire. Stop the procedure. Determine the cause of resistance under fluoroscopy and take appropriate remedial action. If the guide wire is moved excessively, it may be damaged including separation or the like, which may cause blood vessel injury or result in fragments being left inside the vessel; (warnings) when torquing this guide wire inside the blood vessel, do not torque continuously in the same direction. It may be damaged including separation or the like, which may injure the blood vessel or leave fragments inside the vessel. When torquing the guide wire, rotate it clockwise and counterclockwise alternately. Do not exceed two rotations (up to 720?? ) in the same direction; and, (malfunction and adverse effects) damage such as separation.
Patient Sequence No: 1, Text Type: N, H10
[108734153]
It was reported that the distal segment of the subject guide wire became damaged during a procedure to treat an arteriovenous fistula in the cavernous sinus. A new guide wire was replaced and the procedure was successfully completed. The physician commented that no particular intervention was taken against the damaged wire. The wire was used for long time so that it became damaged. The patient was being without problem after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2018-00095 |
| MDR Report Key | 7513230 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-05-14 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-04-17 |
| Date Mfgr Received | 2018-04-23 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2018-05-14 |
| 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 | YUKAKO HOMMA |
| Manufacturer Street | 3-100 AKATSUKI-CHO |
| Manufacturer City | SETO, AICHI 489-0071 |
| Manufacturer Country | JA |
| Manufacturer Postal | 489-0071 |
| Manufacturer G1 | ASAHI INTECC CO., LTD. |
| Manufacturer Street | 3-100 AKATSUKI-CHO |
| Manufacturer City | SETO, AICHI 489-0071 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 489-0071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASAHI CHIKAI |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2018-05-14 |
| Returned To Mfg | 2018-04-23 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-200 |
| Lot Number | 180122A56A |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2018-05-14 |