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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 10/02/2017
Event Type  Injury  
Manufacturer Narrative
The patient was treated with an admiral xtreme balloon catheter during the index procedure. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Cec adjudicated that event is not related to the procedure or therapy but related to the device. Revascularization is clinically driven. Cec reported that there was thrombus at the anastomosis. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Sponsor assessed that the event as not related to the index device, procedure or paclitaxel. 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 the index procedure the anastomosis of the right arm received pre-dilation from an unknown mdt balloon and was treated with another unknown mdt balloon. It was reported that 2 months post index shunt occlusion occurred. This was treated with medication and a pta was used to treat the anastomosis. The patient received surgical intervention. The event is reported as resolved. The investigator assessed the event as not related to the index device, procedure or paclitaxel.
 
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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 Key6999775
MDR Text Key109694244
Report Number3004066202-2017-00107
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,Followup,Followup
Report Date 09/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2017
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 Received08/09/2018
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: 11/03/2017 Patient Sequence Number: 1
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