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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN POWERCROSS 018 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN POWERCROSS 018 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/01/2014
Event Type  Injury  
Event Description
Two powercross balloon were used to treat occlusion of the left sfa and popliteal arteries. Approximately 5 months post use of these balloons, restenosis in the sfa occurred which was treated with pta balloon revascularisation. Approximately 10 months post use, restenosis of the left sfa and popliteal artery occurred which was treated with pta balloon revascularisation. Approximately 15 months post use, restenosis of the left sfa and popliteal artery occurred which was treated with pta balloon revascularisation. Approximately 20 months post use, occlusion of the left sfa occurred which was treated pta balloon and deb revascularisation.
 
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Brand NamePOWERCROSS 018
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 Key6787577
MDR Text Key82458652
Report Number2183870-2017-00343
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K093286
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 07/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2017
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 Received07/12/2017
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: 08/11/2017 Patient Sequence Number: 1
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