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: Other
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR