ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE WAIN-CKI-200

MAUDE Adverse Event Report

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..

Event Text Entries

[70178191] 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 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


[70178192] On (b)(6) 2016: coil embolization was conducted to an unruptured left intimal carotid artery aneurysm. On (b)(6) 2016: the patient was discharged from the hospital. On (b)(6), 2016: at 2:40 pm, the patient was admitted to er after having aphasia and spasm. At 5:15 pm, the patient became able to understand instructions and to respond to a verbal contact. On (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. On (b)(6) 2016: the patient was discharged from the hospital. On (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. On (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


MAUDE Entry Details

Report Number3003775027-2017-00037
MDR Report Key6412512
Report SourceDISTRIBUTOR
Date Received2017-03-17
Date of Report2017-03-17
Date of Event2016-11-15
Date Mfgr Received2017-02-17
Device Manufacturer Date2016-09-06
Date Added to Maude2017-03-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactYUKAKO HOMMA
Manufacturer Street3-100 AKATSUKI-CHO
Manufacturer CitySETO, 489-0071
Manufacturer CountryJA
Manufacturer Postal489-0071
Manufacturer Phone561485551
Manufacturer G1ASAHI INTECC CO., LTD.
Manufacturer Street3-100 AKATSUKI-CHO
Manufacturer CitySETO, 489-0071
Manufacturer CountryJA
Manufacturer Postal Code489-0071
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASAHI CHIKAI NEUROVASCULAR GUIDE WIRE
Generic NameNEUROVASCULAR GUIDE WIRE
Product CodeMOF
Date Received2017-03-17
Model NumberNA
Catalog NumberWAIN-CKI-200
Lot Number160823A05A
Device Expiration Date2019-07-31
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASAHI INTECC CO., LTD.
Manufacturer Address3-100 AKATSUKI-CHO SETO, 489-0071 JA 489-0071


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2017-03-17

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