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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Blood Loss (2597)
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 a cardiovascular surgeon practicing in (b)(6) who within the last 12 months used an evercross pta balloon catheter for dilatation of stenoses in the iliac arteries (11 procedures), femoral arteries (5 procedures), ilio-femoral arteries (12 procedures), popliteal arteries (9 procedures), infra-popliteal arteries (13 procedures), and renal arteries (7 procedures). The evercross pta balloon catheter was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae (10 procedures) and for stent post dilatation in the peripheral vasculature (7 procedures). This cardiovascular surgeon also used a fortrex pta balloon catheter for dilatation of stenoses in the iliac arteries (8 procedures), femoral arteries (6 procedures), ilio-femoral arteries (11 procedures), popliteal arteries (8 procedures), infra-popliteal arteries (13 procedures), and renal 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) and for stent post dilatation in the peripheral vasculature (12 procedures). Related to the evercross pta balloon catheter, one bleeding requiring transfusion event is reported during dilatation of stenoses in the iliac arteries. One infection event is reported during dilatation of stenoses in the ilio-femoral arteries. Both of these events are reported to be somewhat concerning and device related. Immediate acute bleeding is reported for the bleeding event requiring transfusion. The infection is described as puncture wound exudate. Related to the fortrex pta balloon catheter, one fever event is reported during dilatation of stenoses in the femoral arteries, and during treatment of obstructive lesions of nat ive or synthetic arteriovenous dialysis fistulae. One hematoma event is reported during dilatation of stenoses in the iliac arteries, ilio-femoral arteries, popliteal arteries, renal arteries, as well as during stent post dilatation in the peripheral vasculature. One intraluminal thrombus event is reported during dilatation of stenoses in the infra-popliteal arteries. The fever event was reported to be somewhat concerning and device related. The fever event occurred less than 24 hours post treatment. The hematoma event (large superficial hematoma) and intraluminal thrombus event are reported to be not at all concerning. The hematoma event is reported to be device related also. The intraluminal thrombus is reported to not be device related.

 
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Brand NameEVERCROSS 035
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 Key9009940
MDR Text Key162332521
Report Number2183870-2019-00445
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK082579
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 09/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/12/2019
Is This An Adverse Event Report? Yes
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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