MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-03-17 for ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE WAIN-CKI-200 manufactured by Asahi Intecc Co., Ltd..
[70171675]
Manufacturing site: (b)(4). Attempts were made to gather thorough event information during complaint processing; the physician commented that the root cause could not be identified. Although the event is less likely to be attributed to release foreign substance, the possibility cannot be completely denied. As the patient was being administered a medicine (steroid), its side effect could be considered as a contributory factor as well. Investigation of the device could not be conducted since it was not returned. Lot history revealed no anomaly related to the reported event, and no other similar product experience or peeling of coating was reported. Based on the obtained information, it is presumed that there was no deficiency with the device in question as there was no anomaly found in the production record. The lot history did not present any malfunction information that could be related to this event. However, as the device was not returned, it was concluded involvement of the device in the event could not be denied. Malfunction and adverse effects section of the ifu states: allergic reaction.
Patient Sequence No: 1, Text Type: N, H10
[70171676]
(b)(6) 2016: coil embolization was conducted to an unruptured left intimal carotid artery aneurysm. (b)(6) 2016: the patient was discharged from the hospital. (b)(6) 2016: at 2:40pm, the patient was admitted to er after having aphasia and spasm. At 5:15pm, the patient became able to understand instructions and to respond to a verbal contact. (b)(6) 2016: head mri and angiographic head mri were conducted, and expression of hia (high intensity area) was confirmed. Observation of the mri image suggested this hia could be attributed to an inflammatory change due to release of foreign substance into a peripheral vessel. (b)(6) 2016: the patient was discharged from the hospital. (b)(6) 2016: at the outpatient examination, the patient had a clear sensorium, showing no symptom of aphasia or spasm. The hia that had been confirmed during the previous admission looked disappeared, but a new hia expression was confirmed at the left frontal lobe. (b)(6) 2017: at the outpatient examination mri was conducted, but the hia looked disappeared, indicating no anomaly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003775027-2017-00036 |
| MDR Report Key | 6412510 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-03-17 |
| Date of Report | 2017-03-17 |
| Date of Event | 2016-11-15 |
| Date Mfgr Received | 2017-02-17 |
| Device Manufacturer Date | 2016-08-04 |
| Date Added to Maude | 2017-03-17 |
| 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 | 2017-03-17 |
| Model Number | NA |
| Catalog Number | WAIN-CKI-200 |
| Lot Number | 160726A28A |
| Device Expiration Date | 2019-06-30 |
| 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. Hospitalization; 2. Other | 2017-03-17 |