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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN CHOCOLATE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN CHOCOLATE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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 the chocolate balloon. Survey results received for a vascular surgeon with 40 years of experience who has been using the chocolate balloon since 2014. The physician has used a total of 210 chocolate balloons, with 41 of these being used in the past 12 months for dilatation of stenoses in the femoral arteries, popliteal arteries, and infra-popliteal arteries. The respondent reports device related complications of disconnection of nitinol cage from the balloon which was not previously reported to medtronic and was considered to be somewhat concerning.
 
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Brand NameCHOCOLATE
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 Key9456942
MDR Text Key195247547
Report Number2183870-2019-00581
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K130414
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 12/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received12/06/2019
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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