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U.S. Department of Health and Human Services

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

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ASAHI INTECC CO., LTD. ASAHI FUBUKI PERCUTANEOUS CATHETER Back to Search Results
Catalog Number WAIN-FBK-6S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 06/10/2014
Event Type  Injury  
Manufacturer Narrative
(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.
 
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Brand NameASAHI FUBUKI
Type of DevicePERCUTANEOUS 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, 489-0 071
JA 489-0071
Manufacturer Contact
yukako homma
3-100 akatsuki-cho
seto, aichi 489-0-071
JA   489-0071
MDR Report Key7463583
MDR Text Key106584118
Report Number3003775027-2018-00085
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K141981
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2015
Device Catalogue NumberWAIN-FBK-6S
Device Lot Number2700210141
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/20/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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