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

Catalog Number AIN-FBK-6MH

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: asahi intecc (b)(4).Attempts were made to gather thorough event information during complaint processing; no further information could be obtained.Device investigation could not be performed because the device was not returned.Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received for this lot.Reviewing of the manufacturing records confirmed no indication of product deficiency.Due to limited information and as device investigation could not be performed, involvement of the subject guide catheter to the reported bleeding could not be ascertained; therefore, a possibility that the guide catheter might cause or contribute to the reported bleeding could not be completely ruled out.Malfunctions and adverse effects section of the instructions for use (ifu) states bleeding complications.

Event Description

It was reported that small bleeding occurred after a procedure to treat an aneurysm where an asahi guide catheter was used.Reportedly no additional intervention was performed against this bleeding.The patient had been under a routine outpatient monitoring.

Manufacturer Narrative

Asahi intecc has determined that the date recorded in block b4 "date of this report" was erroneously reported as the date the report was submitted rather than the date the initial reporter provided the information about the event to the company.Corrective action has been taken to clarify which date should be provided in the report.This supplemental report is intended only to correct the date provided to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI FUBUKI HARD
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 7463581
• MDR Text Key: 106583195
• Report Number: 3003775027-2018-00084
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327105798
• UDI-Public: (01)04547327105798(17)200331(30)1(10)170427C261
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: AIN-FBK-6MH
• Device Lot Number: 170427C261
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1