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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AXIUS CORONARY SHUNT 1.5 MM CLAMP, VASCULAR

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AXIUS CORONARY SHUNT 1.5 MM CLAMP, VASCULAR Back to Search Results
Catalog Number C-OF-1500
Device Problem Device Expiration Issue (1216)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A lot history record review was completed for the reported product lot number. There was no nonconformance recorded in the lot history. Since the device is not available to be returned to us, a technical evaluation cannot be performed. Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
 
Event Description
The hospital reported that they noticed post use/procedure that the expiration date was expired on a axius coronary shunt 1. 5mm that was used during a coronary artery bypass procedure. There was no harm to the patient. The shunt was discarded after use.
 
Event Description
The hospital reported that they noticed post use/procedure that the expiration date was expired on a axius coronary shunt 1. 5mm that was used during a coronary artery bypass procedure. There was no harm to the patient. The shunt was discarded after use.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameAXIUS CORONARY SHUNT 1.5 MM
Type of DeviceCLAMP, VASCULAR
MDR Report Key7478243
MDR Text Key107199517
Report Number2242352-2018-00406
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K010117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/22/2017
Device Catalogue NumberC-OF-1500
Device Lot Number25117653
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2018
Is This a Reprocessed and Reused Single-Use Device? No

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