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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVATEC SPA ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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INVATEC SPA ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Occlusion (1984); Thrombus (2101)
Event Date 09/12/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient had a revascularisation of the right popliteal using an admiral extreme pta balloon catheter. Approximately 23 months post use of the admiral extreme, the patient suffered thrombotic occlusion of the femoropopliteal bypass graft on right limb. Recanalisation was performed using catheter directed thrombolysis and a pta device. The event was resolved.
 
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Brand NameADMIRAL XTREME
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
INVATEC SPA
via martiri della liberta, 7
roncadelle 25030
IT 25030
Manufacturer (Section G)
INVATEC SPA
via martiri della liberta, 7
roncadelle 25030
IT 25030
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7027320
MDR Text Key91882025
Report Number3004066202-2017-00109
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K062809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/14/2017 Patient Sequence Number: 1
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