Catalog Number AIN-FBK-6MH |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Intracranial Hemorrhage (1891)
|
Event Date 03/27/2018 |
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.
|
|
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 in block b4 to reflect the date the initial reporter provided the information about the event to the company.
|
|
Search Alerts/Recalls
|