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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
Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
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 the chocolate pta balloon during procedure to treat severely calcified plaque in the distal mid left superficial femoral artery(sfa). The vessel had moderate tortuosity and exhibited cto (chronic total occlusiom-100%). The artery diameter was 6mm and lesion length was 180mm. A 6fr sheath was 0. 018'' guidewire were used. Physiological inflation fluid was used. There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray. There was no alleged product issue. The device was passed through a previously deployed stent. No resistance was encountered when advancing the device. Patient nothing happened. It was reported that the physician misused the device inside a newly implanted stent. Confirming the device the stent meshes were incarcerated in the balloon cage so physician had to carry out repeated inflating and deflating maneuvers to detach the anchorage of the cap with the stent. After repeated operations he managed to swallow the device and take it out. Physician has acknowledged that they used chocolate under a no ifu condition resulting in a serious error of procedures and evaluation of the procedure. There was no damage caused to the stent. There was no intervention required to remove the balloon from the stent. There cage did not detach off the balloon. The device did not give any problems of any kind. 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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key13151119
MDR Text Key289665823
Report Number2183870-2022-00004
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIT
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
Report Date 01/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2022
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
Date Manufacturer Received12/15/2021
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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