MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI FUBUKI 043; PERCUTANEOUS CATHETER

Catalog Number WAIN-FBK-4-130

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Granuloma (1876)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing site could not be determined because the product lot number information was not available.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.No other similar product experience report was received.Investigation of the production record could not be performed as lot information was unavailable.Although lot history review could not be conducted, since all the shipped products were inspected in the production process for meeting the product specifications and release criteria, there was no indication of product deficiency.As the subject device passed all manufacturing inspections, it was concluded that there was no device defect.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.

Event Description

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.

• Brand Name: ASAHI FUBUKI 043
• Type of Device: PERCUTANEOUS 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: 7044284
• MDR Text Key: 92473273
• Report Number: 3003775027-2017-00208
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141981
• 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: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: WAIN-FBK-4-130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention