MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. FUBUKI XF; GUIDE CATHETER

Catalog Number FBKX-8A90DY

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/17/2022

Event Type  Injury  

Event Description

It was reported that a coil embolization of the ophthalmic artery aneurysm was performed and successfully completed without any issues.The patient had a fever after the procedure likely due to allergy.The fever had already subsided.Several devices were used in the procedure including an asahi fubuki xf guide catheter, an asahi chikai black 14 soft tip guide wire, an asahi chikai black guide wire, an asahi chikai guide wire and non-asahi devices.

Manufacturer Narrative

Manufacturing site: (b)(4).Device evaluation could not be performed because the affected device was not returned.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.More than (b)(4) units of fubuki series have been sold so far, but no other report of fever due to allergy was received.There was no record to show anomaly from lot history record review and no other product experience report associated with this event was received from this lot; therefore, it was concluded that this event was not attributed to product quality.However, it was unable to completely rule out a possibility that the fubuki xf might have contributed to this event.No capa will be taken.Instructions for use (ifu) states: [malfunction and adverse effects].Allergic reaction.

• Brand Name: FUBUKI XF
• Type of Device: GUIDE CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 16040570
• MDR Text Key: 306069447
• Report Number: 3003775027-2022-00171
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K213589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FBKX-8A90DY
• Device Lot Number: 220825C321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other