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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN NANOCROSS ELITE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN NANOCROSS ELITE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); 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 the performance of medtronic¿s nanocross and rapidcross pta balloons. Survey results received for an interventional radiologist with 21 years¿ experience who has been using both the nanocross pta balloon and rapidcross pta balloon since 2019. The physician has used a total of 375 nanocross balloons, with all of these being used in the past 12 months for dilatation of stenoses in the iliac arteries, femoral arteries, ilio-femoral arteries, popliteal arteries, infra-popliteal arteries, and renal arteries. The nanocross pta was also used for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and for stent post-dilation in the peripheral vasculature. The respondent reports device related complications of arrhythemia (associated with vascular spasms and pseudoaneurysm (within the stochastic norm, no outside spaces) which were not previously reported to medtronic. The events were considered to be somewhat concerning.

 
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Brand NameNANOCROSS ELITE
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 Key9450615
MDR Text Key171612840
Report Number2183870-2019-00576
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK132777
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 12/11/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/11/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2019
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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