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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRIVANT LTD. T/A LAKE REGION MEDICAL VICTORY 14 (300CM, 30G)
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BRIVANT LTD. T/A LAKE REGION MEDICAL VICTORY 14 (300CM, 30G) Back to Search Results
Model Number 901023-30
Device Problem Fracture (1260)
Patient Problem Bone Fracture(s) (1870)
Event Date 02/27/2020
Event Type  malfunction  
Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
 
Event Description
The end of the victory wire sheared off behind a stent today in a patient.There was no patient injury.The physician believed the wire was stuck between the backside of the stent and the outside wall of the vessel so the tip was not floating around and it was stuck in.
 
Event Description
The end of the victory wire sheared off behind a stent today in a patient.There was no patient injury.The physician believed the wire was stuck between the backside of the stent and the outside wall of the vessel so the tip was not floating around and it was stuck in.
 
Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
 
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Brand Name
VICTORY 14 (300CM, 30G)
Type of Device
VICTORY 14 (300CM, 30G)
Manufacturer (Section D)
BRIVANT LTD. T/A LAKE REGION MEDICAL
parkmore west business park
galway, ei
EI 
MDR Report Key9829357
MDR Text Key200630340
Report Number3006010712-2020-00004
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
PMA/PMN Number
K120137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number901023-30
Device Catalogue NumberH74939231300300
Device Lot Number4661677
Was Device Available for Evaluation? No
Date Manufacturer Received03/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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