MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-03-25 for ASAHI CHIKAI 008 N/A WAIN-CKI-008-200 manufactured by Asahi Intecc Co., Ltd..
[139667151]
(b)(4). The guide wire and the separated tip segment with the ball tip attached were returned for evaluation. Microscopic observation revealed that the guide wire was separated approximately 24-25mm distal to the proximal solder designed to sit 90mm proximal to the tip. Fracture surface of the core wire was uneven and circumferential cracks were observed on the core shaft, indicating the core wire fracture was attributed to repeated bending stress. Proximal to the fracture end of the coil wire, coils were found tightened, indicating the coils were wrenched off due to excess torsion. The coil wire of the separated tip segment was helically deformed around the fracture end and stretched at a few points. The core wire was found fractured at approximately 63mm proximal to the tip. Uneven core fracture surface was observed on the core wire just as seen on the proximal fracture end. Coils were also tightened distal to the coil fracture end as seen on the proximal fracture end. Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received. Reviewing of production records found no indication of product deficiency. Based on the investigation results of the returned guide wire, it was concluded that bending stress as well as torsion generated with wire manipulation exceeded the product's design limit while the guide wire was advancing in the severely tortuous vessel. Instructions for use (ifu) states that: [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] never push, auger, withdraw, or press this guide wire with enough force to feel resistance. Pressing or pushing this guide wire against resistance may cause damage and/or tip separation of this guide wire or direct damage to a vessel. Resistance may be felt and/or observed under fluoroscopy by noting any buckling of the tip of the guide wire. If the prolapse of the guide wire tip is observed, do not allow the tip to remain in a prolapsed position. Otherwise damage to the guide wire may occur. Determine the cause of resistance under fluoroscopy and take any necessary remedial action. [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
[139667152]
It was reported that an asahi guide wire was used in combination with a non-asahi microcatheter to access a dural fistula via a severely tortuous vessel. When the physician manipulated the guide wire in attempts to access, he noticed at some point the wire was not moving anymore. The guide wire was taken out of the anatomy when the distal tip was missing. The tip was remained inside the microcatheter; therefore, the separated tip could be successfully removed from the anatomy. The intervention was continued with a non-asahi guide wire. The intervention itself was successful without patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2019-00047 |
| MDR Report Key | 8447004 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-03-25 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-03-05 |
| Device Manufacturer Date | 2018-11-12 |
| Date Added to Maude | 2019-03-25 |
| 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 | 2019-03-25 |
| Returned To Mfg | 2019-03-14 |
| Model Number | N/A |
| Catalog Number | WAIN-CKI-008-200 |
| Lot Number | 181101A50A |
| 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 | 2019-03-25 |