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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 CB1413540120OTW
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Device Embedded In Tissue or Plaque (3165); Embolism/Embolus (4438)
Event Date 11/05/2021
Event Type  Injury  
Event Description
Patient presented with a significant lesion to the common femoral artery, as well as the sfa/pop. Physician used a chocolate pta balloon with a 4/5fr slender sheath and 0. 014 non-medtronic 320cm guidewire during treatment of an 80mm calcified lesion in the patient's mid right anterior tibial artery. Slight vessel tortuosity and severe calcification are reported. Lesion exhibited 95% stenosis. Artery diameter reported as 4mm. The physician was unsuccessful in crossing from an antegrade approach and obtained pedal access to the anterior tibial artery, and inserted a 4/5 sheath. The physician was successfully able to cross the sfa pop lesion, and utilized a non-medtronic device to perform atherectomy. The physician requested a chocolate pta for post atherectomy balloon angioplasty. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray. No issues were noted when removing the device from the hoop/tray. The device was prepped as per ifu without issue. A non-medtronic inflation device was used with 60/40 saline to contrast inflation fluid for balloon inflation. The device was not passed through a previously deployed stent, no resistance was noted during advancement. The chocolate balloon crossed the lesion with no issues and inflated properly. Upon removal of the chocolate pta, the physician encountered some resistance in the anterior tibial artery as the balloon was walked back. The physician believed that the chocolate balloon could possibility be caught in some calcified, and asked the technician to rapidly and slightly inflate the balloon and immediately deflate to create a negative suction. This was performed, and the chocolate balloon was successfully removed from the body. On removal of the device on the table the balloon was immediately inspected and it was noticed that the cage was no longer on the balloon. It was confirmed that the cage was embolized in the mid-anterior tibial artery. The physician then preformed 2 subsequent balloon inflations with a 1. 0, and 2. 0mm coronary balloons to restore a lumen to that portion of the artery. Patency was confirmed via angiography and the case was terminated. Upon removal of the pedal access sheath, doppler pulses were confirmed to the anterior tibial/dorsalis pedis. No injury reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key12787259
MDR Text Key280697796
Report Number2183870-2021-00410
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCB1413540120OTW
Device Lot NumberB5150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/02/2021
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: 11/10/2021 Patient Sequence Number: 1
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