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U.S. Department of Health and Human Services

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

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INVATEC SPA ADMIRAL XTREME OTW CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number SBI060080080
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stenosis (2263); Patient Problem/Medical Problem (2688)
Event Date 12/19/2017
Event Type  Injury  
Manufacturer Narrative
The lot number for the admiral xtreme pta used during the index procedure was provided. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During index procedure, a medtronic standard pta was used to treat lesion in the anastomosis in the left arm. Three months later shunt stenosis occurred in the target lesion. Three days later surgical intervention was carried out in the target lesion to treat the stenosis. Patient recovered. Investigator assessed that the event is not related to the study device, procedure and therapy.
 
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Brand NameADMIRAL XTREME OTW
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 Key7202968
MDR Text Key109695860
Report Number3004066202-2018-00003
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Catalogue NumberSBI060080080
Device Lot Number210346243
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 Received02/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/30/2015
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: 01/18/2018 Patient Sequence Number: 1
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