MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-09 for ASAHI CHIKAI 008 WAIN-CKI-008-200 manufactured by Asahi Intecc Co., Ltd..
[174274782]
Manufacturing site: (b)(4). The chikai 008 guide wire was returned for evaluation. The coil wire of the returned guide wire was fractured distal to the mid solder welding the coil wire onto the core wire that originally located at 25mm from the tip. Proximal to the mid solder, coils were disarranged due to accumulated torsion. At approximately 4. 5mm distal to the mid solder, the exposed core wire was found fractured. Observation by scanning electron microscope was performed. It revealed that the core wire had an uneven, stepped fracture surface that indicated bending stress had contributed to the core fracture. The fracture end of the coil wire was twisted likely due to torsion generated when the coil structure was straightened as the coil wire was pulled. Measurement of the returned guide wire suggested that approximately 21mm of the core wire and approximately 25mm of the coil wire with the underlying inner coil wire were missing. Lot history review revealed no anomaly relating to the reported event. No other similar product experience report was received from this lot. Based on the obtained information and investigation outcome, it was presumed that torsion and bending stress generated with wire manipulation in attempts to find a preferable collateral channel had locally applied on the guide wire. When the applied stress exceeded the product design limit, it caused observed coil disarrangement and fracture of the core wire that also deteriorated sliding ability of the guide wire inside the catheter lumen, and therefore, reported resistance was met. Further applied tensile stress generated with wire removal had likely caused separation of the coil wire. It was concluded that this event was not attributed to product quality. Since the returned guide wire had missing parts, it was unable to completely rule out potentiality that wire fragments might be left in the vessel. Instructions for use (ifu) states: [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] do not push the guide wire more than necessary to advance the tip through the narrowed part of the vessel. (for example, do not push the guide wire when the distal tip of the guide wire is bent by the force of manipulation. ) after crossing the targeted area, do not roughly twist, push or pull the guide wire. If the device is moved excessively, it may be damaged including separation or the like, which may injure the blood vessel or leave fragments 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; [precautions] do not repeatedly bend and stretch the same position of the guide wire, or continuously turn it in a curved vessel for a long period of time; and, [malfunction and adverse effects] damage such as separation.
Patient Sequence No: 1, Text Type: N, H10
[174274783]
It was reported that an asahi chikai 008 guide wire broke during treatment for a type 2 endoleak in the abdominal vessel. The guide wire was used to lead a microcatheter to the affected site. When the guide wire was removed for injecting embolic agent, strong resistance was felt and the guide wire was observed almost separated in two pieces under the fluoroscopy. The guide wire and microcatheter were removed together and no wire fragment was left in the vessel. Wire damage occurred during attempts to embolize the last undecidable vessel so that the physician determined not to embolize the vessel and completed the procedure. There were no adverse patient effects related to the reported wire damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2020-00007 |
| MDR Report Key | 9568026 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-09 |
| Date of Report | 2019-12-18 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2019-04-18 |
| Date Added to Maude | 2020-01-09 |
| 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 008 |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2020-01-09 |
| Returned To Mfg | 2019-12-23 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-008-200 |
| Lot Number | 181029A08A |
| 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 | 1. Other | 2020-01-09 |