MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI FUBUKI 6FR ANGLE; PERCUTANEOUS CATHETER

Catalog Number WAIN-FBK-6A110

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

(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.

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 6FR ANGLE
• 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: 7044286
• MDR Text Key: 92474159
• Report Number: 3003775027-2017-00209
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327088862
• UDI-Public: (01)04547327088862(17)191031(30)1(10)161104C121
• 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 Expiration Date: 10/31/2019
• Device Catalogue Number: WAIN-FBK-6A110
• Device Lot Number: 161104C121
• 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
• Date Device Manufactured: 11/12/2016
• 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