MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-01-13 for ASAHI CHIKAI 200CM WAIN-CKI-200 manufactured by Asahi Intecc Co., Ltd..
[35918005]
(b)(4). This incident information was provided by medical device company of the medical device that was used in the same procedure where asahi guidewire was used. The guidewire was not returned for manufacturer's investigation. Lot history review could not be done since no lot information was available, while all the shipped products are inspected in the production process for meeting the products specifications and release criteria, there is no indication of a product deficiency. Based on the provided information, no perforation was observed while slight leakage of contrast media was seen, detail of the event could not be revealed. Pt exhibited further aggravation of the level, etc. Eleven days after the procedure, and expired the next day. The relation and contribution of the guidewire with ant to the event could not be determined. Ifu describes in warning section: this guide wire must be used only by a physician who is fully trained in neuroradiology treatment. Always advance and withdraw the guide wire slowly. 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. Death as adverse effects.
Patient Sequence No: 1, Text Type: N, H10
[35918006]
This incident information was provided on (b)(6) 2015 by medical device company of the medical device that was used in the same procedure where asahi guidewire was used. (b)(6) 2011, procedure to remove the embolization at left middle cerebral artery m1, thrombectomy was performed by "merci," however it could not complete the revascularization. Asahi chikai and unknown microcatheter was advanced in order to attempt mechanical crushing, physician noticed the leakage of the contrast media at sylvian fissure while no vessel perforation was confirmed. The leakage immediately disappeared, physician completed the revascularization at m2 trunk, and the procedure was completed. Ct observation immediately after the procedure showed very slight leakage of contrast media, and next day subarachnoid hemorrhage and intracerebral bleeding was observed. Aggravation of the level and paralysis at right also dysphasia was observed firstly, however there were recovered afterward. Eleven days after the procedure, further aggravation of level and cerebral embolization at opposite side of middle cerebral artery was observed, seizure, next day the pt expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2016-00002 |
| MDR Report Key | 5365487 |
| Report Source | OTHER |
| Date Received | 2016-01-13 |
| Date of Report | 2015-12-25 |
| Date of Event | 2011-06-25 |
| Date Mfgr Received | 2015-12-25 |
| Date Added to Maude | 2016-01-13 |
| 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 | EIICHI KUBO |
| Manufacturer Street | 3-100 AKATSUKI-CHO, |
| Manufacturer City | SETO, 4890071 |
| Manufacturer Country | JA |
| Manufacturer Postal | 4890071 |
| Manufacturer Phone | 561485551 |
| Manufacturer G1 | ASAHI INTECC CO., LTD. |
| Manufacturer Street | 3-100, AKATSUKI-CHO, |
| Manufacturer City | SETO, 4890071 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 4890071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASAHI CHIKAI 200CM |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2016-01-13 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-200 |
| Lot Number | UNK |
| 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, 4890071 JA 4890071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-01-13 |