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

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.

• Brand Name: CHOCOLATE
• Type of Device: CATHETER, 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 Key: 11627411
• MDR Text Key: 251168994
• Report Number: 2183870-2021-00132
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K130414
• Number of Events Reported: 1
• 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 Received: 04/07/2021
• 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 Received: 03/30/2021
• 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