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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Inflammation (1932); Pseudoaneurysm (2605)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the evercross pta balloon catheter. Survey results received for an interventional radiologist practicing in italy who within the last 12 months used an evercross pta balloon catheter for dilatation of stenoses in the iliac arteries (3 procedures), femoral arteries (8 procedures), popliteal arteries (8 procedures), and infra-popliteal arteries (8 procedures). The evercross pta balloon catheter was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (9 procedures). This interventional radiologist also used a fortrex pta balloon catheter for dilatation of stenoses in the iliac arteries (2 procedures), dilatation of stenoses in the femoral arteries (6 procedures), dilatation of stenoses in the popliteal arteries (6 procedures), and dilatation of stenoses in the infra-popliteal arteries (6 procedures). Related to the evercross pta balloon catheter, three fever events are reported during use for dilatation of stenoses in the femoral arteries, popliteal arteries and infra-popliteal arteries. Two infection events are reported during use for dilatation of stenoses in the femoral arteries, popliteal arteries, and infra-popliteal arteries. One pseudoaneurysm event is reported during use for dilatation of stenoses in the iliac arteries. These three events are reported to be somewhat concerning. All fever events are reported to be device related and occurred in diabetic patients. The pseudoaneurysm event is reported to be device related but can possibly be attributed to procedural error. The infection events are reported to have not been device related at all. Related to the fortrex pta balloon catheter, one fever event is reported during dilatation of stenoses in the popliteal and infra-popliteal arteries. One inflammation event is reported during dilatation of stenoses in the popliteal and infra-popliteal arteries. One pseudoaneurysm event is reported during dilatation of stenoses in the popliteal and infra-popliteal arteries. These three events were reported to be somewhat concerning. These events were reported to be device related but it is reported for the fever and inflammation events the patient was diabetic and there was procedural error associated with the pseudoaneurysm event.

 
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Brand NameFORTREX 0.035 OTW PTA BALLOON CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9127846
MDR Text Key163159640
Report Number2183870-2019-00471
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK142654
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 09/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2019
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

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