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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Perforation (2001); Stenosis (2263); Injury (2348); Vascular Dissection (3160)
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 the chocolate balloon. Survey results received for a cardiothoracic surgeon with 14 years of experience who has been using the chocolate balloon since 2015. The physician has used a total of 1008 chocolate balloons, with 224 of these being used in the past 12 months for dilatation of stenoses in the iliac arteries, femoral arteries, popliteal arteries, infra-popliteal arteries, and renal arteries. The respondent reports device related complications of arterial dissection or perforation, arteriovenous fistula, restenosis of treated artery, and surgical repair of vascular site which was all previously reported to medtronic. The respondent reports device related complications of hemorrhage or hematoma and infection (local or systemic) which was not previously reported to medtronic. The hemorrhage or hematoma, infection (local or systemic), surgical repair of the vascular access site, and intimal lesion events were considered to be not at all concerning. The arterial dissection or perforation, arteriovenous fistula, and restenosis of treated artery events were 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 Key9456953
MDR Text Key185723895
Report Number2183870-2019-00582
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK130414
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
1 Patient Was Involved in the Event
Date FDA Received12/12/2019
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 Received12/06/2019
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

Patient TREATMENT DATA
Date Received: 12/12/2019 Patient Sequence Number: 1
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