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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 CB1413540040OTW
Device Problems Use of Device Problem (1670); Device Damaged by Another Device (2915); Compatibility Problem (2960)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician used a chocolate pta balloon with a 6fr 45cm non-medtronic sheath and non-medtronic 0. 014 guidewire during treatment of  the patient's mid and distal right popliteal artery and tibial/popliteal trunk. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray. There were no issues 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 contrast saline for balloon inflation. The device was passed through a previously deployed stent. No resistance was noted during advancement.  after the balloon was deflated and was being removed, the nitinol cage of this chocolate balloon accidentally interacted with distal part of newly implant non-medtronic self-expanding (se) stent, which was implanted in same procedure and proximal to the balloon. The chocolate balloon was not used as post dilation. The distal part of stent was damaged a little and migrated proximally, according to the physician. The nitinol cage of the balloon was damaged and very little portion detached in the vessel. The chocolate balloon was removed successfully and the stent implanted was post dilated with a non-medtronic balloon. It is not sure if there was vessel injury, but flow was patent. No further injury reported.
 
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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 Key13190156
MDR Text Key291381183
Report Number2183870-2022-00012
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeHK
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,Followup,Followup,Followup
Report Date 05/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCB1413540040OTW
Device Lot NumberB4481
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2020
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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