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U.S. Department of Health and Human Services

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

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COVIDIEN CHOCOLATE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Catalog Number CB1415030120OTW
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a chocolate pta balloon during procedure to treat a moderately calcified fibrous lesion in the mid anterior tibial artery (ata) with 60% stenosis. The vessel was little tortuous. No embolic protection was used. There was no damage noted to packaging. There was no issue noted when removing device from hoop/tray. The device was prepped per ifu with no issues identified. It was reported that during delivery through the vessel, break/fracture occurred. The catheter was removed. The device passed through a previously deployed stent. There was no resistance encountered when advancing the device. Physician replaced with anotherbrand balloon to complete the procedure. There was no patient injury.
 
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Brand NameCHOCOLATE
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13677966
MDR Text Key286655984
Report Number2183870-2022-00076
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K130414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCB1415030120OTW
Device Lot Number1034326
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/06/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/28/2021
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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