MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-06-28 for ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE WAIN-CKI-200 manufactured by Asahi Intecc Co., Ltd..
[78544899]
Manufacturing site: asahi intecc hanoi co. , ltd. (b)(4). Attempts were made to gather thorough event information during complaint processing; the physician commented that the bleeding was not related to the stent. It was due to the deployed stent. No further information could be obtained. The device investigation could not be conducted as the device was not returned to the manufacturer. Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received. Although the device investigation 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. As the physician's comment, the bleeding was very likely attributed to the deployed stent; however, a possibility of the guidewire's relation to the bleeding could not be ruled out and thus this incident was considered reportable. The ifu states: [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]: 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]: the distal end excels in vascular selectivity. However, if it is advanced into a thin peripheral area of the vessel, the penetrating force in the vessel becomes stronger, and there will be a higher risk of vessel damage such as vessel perforation. Therefore, when manipulating the guide wire or having a micro catheter or the like follow it, take extreme care. In particular, in a procedure for collecting or suctioning blood clots for acute cerebrovascular occlusion, the guide wire manipulation becomes a blind manipulation to an occluded peripheral area for which there is no anatomical information of the vessel, therefore, more careful manipulation will be required. Do not perform catheter manipulation with the distal end of the guide wire being secured to the collateral since it will increase the risk of vessel perforation; [precautions]: during the procedure, always check the distal end of the guide wire under fluoroscopy. In particular, in cases where the guide wire is not directly manipulated, such as moving the other devices used over the guide wire or performing kissing technique, always pay attention to the movement of the distal end of the guide wire so that the guide wire will not damage the vessel; and, [malfunction and adverse effects]: damage to a vessel, including possible vessel perforation.
Patient Sequence No: 1, Text Type: N, H10
[78544900]
During a coil embolization to treat an unruptured aneurysm in the bifurcation of the ophthalmic artery, four coils were placed and the embolization was completed. When the microcatheter was withdrawn from the aneurysm, a part of the coil intruded into the main stream. In order to place the intruded coil, a stent was deployed in the neck of the aneurysm. Because the distal of the sent could not be fully expanded, a microcatheter and the subject guidewire were advanced into the middle cerebral artery. When the angiogram was taken, bleeding was observed at either the stent distal or the ic-top. Heparin reversal was taken and a balloon was inflated proximal to the bleeding; however, both went unsuccessful and mydriasis was observed so that the patient was transferred to the operating room for craniotomy. The patient had been in critical condition postoperatively and died on (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2017-00098 |
| MDR Report Key | 6672549 |
| Report Source | OTHER |
| Date Received | 2017-06-28 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-05-18 |
| Date Mfgr Received | 2017-05-31 |
| Device Manufacturer Date | 2017-02-09 |
| Date Added to Maude | 2017-06-28 |
| 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, 489-0071 |
| Manufacturer Country | JA |
| Manufacturer Postal | 489-0071 |
| Manufacturer Phone | 561485551 |
| Manufacturer G1 | ASAHI INTECC CO., LTD. |
| Manufacturer Street | 3-100 AKATSUKI-CHO |
| Manufacturer City | SETO, 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 NEUROVASCULAR GUIDE WIRE |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2017-06-28 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-200 |
| Lot Number | 170119A63A |
| Device Expiration Date | 2019-12-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Death | 2017-06-28 |