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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Perforation (2001); Stenosis (2263); Injury (2348); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess the performance of the chocolate balloon.Survey results received for a cardiothoracic surgeon with 14 years of experience who has been using the chocolate balloon since 2015.The physician has used a total of 1008 chocolate balloons, with 224 of these being used in the past 12 months for dilatation of stenoses in the iliac arteries, femoral arteries, popliteal arteries, infra-popliteal arteries, and renal arteries.The respondent reports device related complications of arterial dissection or perforation, arteriovenous fistula, restenosis of treated artery, and surgical repair of vascular site which was all previously reported to medtronic.The respondent reports device related complications of hemorrhage or hematoma and infection (local or systemic) which was not previously reported to medtronic.The hemorrhage or hematoma, infection (local or systemic), surgical repair of the vascular access site, and intimal lesion events were considered to be not at all concerning.The arterial dissection or perforation, arteriovenous fistula, and restenosis of treated artery events were considered to be somewhat concerning.

• 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 ; 091708734
• MDR Report Key: 9456953
• MDR Text Key: 185723895
• Report Number: 2183870-2019-00582
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• 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