MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-10-29 for ASAHI CHIKAI 008 WAIN-CKI-008-200 manufactured by Asahi Intecc Co., Ltd..
[90515040]
Manufacturing site: manufacturing site could not be determined because the product lot number information was not available. Attempts were made to gather thorough event information during complaint processing; no further information could be obtained. Device investigation could not be conducted as the device was not returned. Investigation of the production record could not be performed as lot information was unavailable. Although the device investigation and lot history review could not be conducted, since all the shipped products were inspected in the production process for meeting the product specifications and release criteria, there was no indication of product deficiency. Based on the obtained information, it was presumed that torque or pushing-pulling force exceeding the product's design limit might be inadvertently applied while it was being trapped by undetermined factor(s) such as concomitant device and led the wire to become fractured. Instructions for use 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] 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
[90515041]
Reportedly, during a procedure to treat an aneurysm, distal part of the subject guide wire became separated. The wire fragment was able to be retrieved.
Patient Sequence No: 1, Text Type: D, B5
[115699452]
Manufacturing site: asahi intecc (b)(4). The subject guide wire including the separated portion approximately 9cm in length was returned for evaluation. The returned guide wire had its coil wire fractured at the proximal solder. At approximately 6. 5cm distal to the proximal solder, the core wire was found fractured. The core wire was deformed in large curve. The coil fracture was microscopically observed. It was found that the outer diameter of the coil wire was getting smaller to the fracture end; it suggested that the coil was fractured due to tensile stress. The core wire was not twisted. Fracture surface of the core wire was uneven. These findings suggested that the core wire was fractured due to repeated bending stress. As seen on the proximal side of fracture, the distal side of both coil and core wires demonstrated the same characteristics. The coil wire had smaller outer diameter and the core wire had uneven fracture surface. By measuring the lengths of the wire fragment and core wire, it was concluded that the entire guide wire was returned. Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received. Based on the obtained information and the investigation outcome, it was presumed that bending stress was repeatedly applied to a focal spot while movement of the guide wire was being restricted due to external factors (not device induced) such as tortuosity of a vessel. When the bending stress exceeded the product design limit, the core wire became fractured. Coil wire fracture was assumed to be caused due to excess pulling stress that could be generated during wire removal. There was no indication of product deficiency. Instructions for use 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; and, [malfunction and adverse effects] damage such as separation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003775027-2017-00194 |
| MDR Report Key | 6986212 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-10-29 |
| Date of Report | 2017-12-18 |
| Date of Event | 2017-10-17 |
| Date Mfgr Received | 2017-11-30 |
| Device Manufacturer Date | 2016-11-16 |
| Date Added to Maude | 2017-10-29 |
| 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 | 2017-10-29 |
| Returned To Mfg | 2017-11-30 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-008-200 |
| Lot Number | 161107A10A |
| Device Expiration Date | 2019-10-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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, 489-0071 JA 489-0071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-29 |