MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-16 for ASAHI CHIKAI 10 WAIN-CKI-10-200 manufactured by Asahi Intecc Co., Ltd..
[139368131]
(b)(4). 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 was helically deformed for approximately 40-60mm proximal to the tip. The coils were found stretched for approximately 9mm proximal to the mid solder set at 25mm proximal to the tip. The inner coil wire was found fractured at approximately 2mm proximal to the mid solder. The coils were removed for fracture observation. The inner coils were tightened at the fracture ends. The inner coils were also removed to expose the core wire. It revealed that the core wire was fractured at the same location as the inner coil wire. On the shaft of the core wire, helical marks were observed. The fracture surface of the core wire was relatively flat. These findings indicated that excess torsion had contributed to the fracture. Despite stretching the coil wire remained in one piece and the fracture surfaces of the inner coil wire and core wire corresponded to each other; therefore, it was concluded that 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 from this lot. Reviewing of production record found no indication of product quality deficiency. Based on the obtained information and investigation outcome, it was concluded that torsion and tensile stress accumulated on the guide wire contributed to the fracture. The stress was accumulated probably due to anatomical condition such as vessel tortuosity that restricted wire movement in the vessel. When the accumulated stress exceeded the product's design limit, it led the inner coil wire and core wire become fractured. Stretching of the coil wire was assumed to attribute to tensile stress generated with wire removal. Instructions for use (ifu) states: [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 (720?? ) in the same direction; and, [adverse reactions/events] breakage of the guide wire.
Patient Sequence No: 1, Text Type: N, H10
[139368132]
It was reported that an asahi guide wire became stretched during an aneurysm embolization of the anterior cerebral artery (aca). The guide wire was delivered with a microcatheter when stretching of the coils was noted under the fluoroscopy. A new guide wire was replaced and the procedure was successfully completed. The patient was without problem after the procedure and discharged after the procedure as planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2019-00027 |
| MDR Report Key | 8346380 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-16 |
| Date of Report | 2019-02-16 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-08-02 |
| Date Added to Maude | 2019-02-16 |
| 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 10 |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2019-02-16 |
| Returned To Mfg | 2019-02-13 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-10-200 |
| Lot Number | 180723A36A |
| 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 | 2019-02-16 |