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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Thrombosis/Thrombus (4440); Restenosis (4576)
Event Date 06/19/2020
Event Type  Injury  
Manufacturer Narrative
Journal title: percutaneous angioplasty in the treatment of thrombosed hemodialysis fistulas: a single-center experience with 1 year of follow-up doi: 10. 5543/tkda. 2020. 33027. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was submitted detailing a study " percutaneous angioplasty in the treatment of thrombosed hemodialysis fistulas: a single-center experience with 1 year of follow-up". 33 patients were included in the study. This study is an evaluation of the success and patency rate of percutaneous balloon angioplasty of thrombosed hemodialysis fistulas using a drug-coated balloon (dcb) contrasted with a standard balloon (sb). Medtronic chocolate pta balloon catheter or a non-medtronic ptca balloon catheter were used in the sb group and a non-medtronic dcb were used in the dcb group. Sb angioplasty was performed with an inflation time of 2minutes at nominal pressure (6 or 9 atm). In the dcb group, pre dilation with a sb was followed by angioplasty with a dcb with an inflation time of 2 minutes at 6 atm. Restenosis were reported in the population at 1, 6 and 12 months post procedure. 1 patient in each group died within 6 months post procedure. At 12 months, one additional patient of each group died. Two patients in each group died due to cardiovascular causes during the follow up period. A minor access site hematoma developed in 3 patients: 1 in a femoral access site and 2 in a brachial access site. The patients were treated conservatively without any need for blood transfusion or surgica l treatment. In 1 patient, angioplasty balloon fracture and embolization occurred during the procedure, however, the embolized part of the balloon was retrieved using a snare catheter without the need for surgery. There was no procedural complication requiring urgent surgery.
 
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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 
EI  
091708734
MDR Report Key11627411
MDR Text Key251168994
Report Number2183870-2021-00132
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K130414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2021
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

Patient Treatment Data
Date Received: 04/07/2021 Patient Sequence Number: 1
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