MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-11-19 for ASAHI CHIKAI BLACK WAIN-CKI-200-BS manufactured by Asahi Intecc Co., Ltd..
[92473998]
Manufacturing site: (b)(4). Attempt was made to gather thorough event information during complaint processing; the physician commented that it could possibly be an allergic reaction to coating agents; however, there was no evidence to support that. Device analysis could not be conducted as the guide wire was not returned. Lot history review revealed no anomaly relating to the reported event. No other similar product experience report including peeling of the coating was received. It was confirmed that manufacturing records showed no anomaly and no other complaints were received for the lot; therefore, it was concluded that there was no indication of product deficiency. However, a possibility could not be completely ruled out that the subject device might cause or contribute to the reported patient harm. Instructions for use (ifu) states "allergic reaction" as one of possible adverse effects.
Patient Sequence No: 1, Text Type: N, H10
[92473999]
After stenting of an intracranial aneurysm, granulomatosis with polyangiitis in the brain was recognized. The patient was treated with steroids during a week of hospitalization. The patient was recovering and rehabilitating such as walking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2017-00207 |
| MDR Report Key | 7044285 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-11-19 |
| Date of Report | 2017-11-20 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2017-11-02 |
| Device Manufacturer Date | 2017-01-05 |
| Date Added to Maude | 2017-11-19 |
| 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 BLACK |
| Generic Name | NEUROVASCULAR GUIDE WIRE |
| Product Code | MOF |
| Date Received | 2017-11-19 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-200-BS |
| Lot Number | 170525A46A |
| 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, AICHI 489-0071 JA 489-0071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-19 |