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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 Problems Difficult to Remove (1528); Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use a chocolate pta balloon during patient treatment. The device was prepped per ifu with no issues identified. The device was passed through a previously deployed stent (non-medtronic). It was reported that during the use of chocolate pta balloon, the balloon was positioned distally of a non-medtronic stent and was entangled when pulled back. The damaged balloon could finally be removed through the guide catheter without any additional tools. The stent was damaged (pulled proximally like a harmonica). A new stent had to be placed. There were no complications to the vessel which was finally successfully treated. There was no patient injury reported.
 
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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 Key10512988
MDR Text Key207542771
Report Number2183870-2020-00289
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSZ
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 09/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2020
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 Received08/28/2020
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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