MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-08-28 for ASAHI CHIKAI WAIN-CKI-200 manufactured by Asahi Intecc Co., Ltd..
[118756659]
(b)(4). When the guide wire was returned to the manufacturer, a reportable malfunction (core wire fracture) was recognized for the first time; therefore, the date the manufacturer became aware of the event was considered the date the device returned. Coils of the returned guide wire were stretched for approximately 35 mm proximal to the middle solder set to be at 40 mm from the wire tip. Under the stretched coils, the inner coil wire was exposed and found fractured at approximately 10 mm proximal the solder. The proximal end of the inner coil wire was soldered; the inner coil wire remained in one piece. The distal solder was found at the end of the stretched coil wire; the coil wire was also remained in one piece. Measuring the length of the core wire, it was concluded that the entire guide wire was returned. Sem was used to observe the fracture surface of the core wire. The fracture surface was relatively flat and demonstrated circular pattern with dimples. These findings suggested that the core wire became fractured due to torsion. To observe the distal side of the core fracture surface, the coil wire and the inner coil wire were removed. The core wire was found fractured at approximately 13 mm from the tip. Sem was also used to observe the fracture surface of the core wire. The distal fracture surface showed the same characteristics observed on the proximal fracture surface. 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 torsion exceeding the product's design limit was inadvertently applied when the wire movement was restricted possibly by tortuous vessel, leading the core wire to become fractured. The coil wire was assumed to be stretched by pulling stress generated along wire removal. There was no indication of product deficiency. Instructions for use (ifu) states: [warnings] if any resistance is felt due to spasm or the guidewire being bent or trapped while operating the guidewire in the blood vessel or removing it, do not move or torque the guidewire. Stop the procedure. Determine the cause of resistance under fluoroscopy and take appropriate remedial action. If the guidewire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel; [warnings] when torquing the guidewire inside the blood vessel, do not torque continuously in the same direction. This may cause the guidewire to become damaged or break apart, causing injury to the blood vessel or leaving fragments inside the vessel. When torquing the guidewire, rotate it clockwise and counterclockwise alternately. Do not exceed two rotations (720 degrees) in the same direction; and, [malfunction and adverse effects] separation or breakage of the guide wire.
Patient Sequence No: 1, Text Type: N, H10
[118756660]
It was reported that the distal segment of an asahi guide wire was damaged during a tace performed for the right hepatic artery. A new guide wire was replaced to successfully complete the procedure. The patient was reportedly without problem after the tace. When the device was returned to the manufacturer on august 6, 2018, reportable malfunction (fracture of the core wire) was recognized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2018-00160 |
| MDR Report Key | 7825489 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-08-28 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-08-06 |
| Device Manufacturer Date | 2018-04-17 |
| Date Added to Maude | 2018-08-28 |
| 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 | 2018-08-28 |
| Returned To Mfg | 2018-08-06 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-200 |
| Lot Number | 180409A24A |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-08-28 |