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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
Catalog Number CB1413535120OTW
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 08/23/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician used a chocolate balloon during treatment of an in-stent restenosed fibrous cto (chronic total occlusion-100%) in the patient¿s mid right tibial/popliteal trunk. Slight tortuosity reported. A non-medtronic inflation device was used for balloon inflation. Ifu was followed and the balloon was prepped without issue. It is reported that during attempted removal of the balloon from the lesion, a break occurred on the catheter leading to a detachment. It is suspected that the balloon became caught on stent strut. A snare was used to retrieve the detached portion from the patient.
 
Manufacturer Narrative
Additional information: a 6fr non-medtronic sheath and 0. 014 guidewire were also used. The chocolate balloon was passed through a previously deployed non-medtronic stent. No damage was caused to the previously deployed stent. Minimal resistance was encountered during removal of the device. The balloon was fully deflated for removal from the patient. The patient is reported to be doing well with a good result achieved. If information is provided in the future, a supplemental report will be issued.
 
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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 Key8934776
MDR Text Key156082687
Report Number2183870-2019-00420
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue NumberCB1413535120OTW
Device Lot NumberF180118500
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 Received09/16/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/18/2018
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: 08/27/2019 Patient Sequence Number: 1
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