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

Catalog Number	CB1812050120OTW
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4): a visual inspection of the returned device found that one of the proximal struts was broken, the device was flushed, and an 0.018¿ guidewire was loaded through the tip and exited the luer with no difficulties.An indeflator was attached to the device and the balloon was inflated to nominal pressure of 6atms and held pressure, the balloon was then inflated to rated burst pressure (rbp) of 12atms and held pressure, medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that a physician was attempting to use a chocolate 018 balloon dilatation device to treat a patient in the mid superficial femoral artery with calcification, fibrous and tortuosity and 80% stenosis.No abnormalities reported in relation to anatomy.Ifu was followed.A non-medtronic sheath (6f destination 45 cm) and a non-medtronic guidewire (glidewire advantage.035 260 cm).Ifu was followed.It was reported that a longitudinal balloon burst occurred, during balloon inflation.After the 35 guidewires passed through the superficial femoral artery, an evercross balloon 3*150 was used to dilate the lesion.Then changed to a v18 guidewire and a chocolate balloon was used to dilate the lesion.First, inflated to 3 atm, and then during inflating to 7 atm, the balloon burst.The balloon was replaced with an 18 balloon from another manufacturer for dilation and the operation was completed with a drug-coated balloon.No health consequences or impact to the patient.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CHOCOLATE
• Common Device Name: CATHETER, 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 Key: 21102168
• Report Number: 2183870-2025-00016
• Device Sequence Number: 8665203
• Product Code: LIT
• UDI-Device Identifier: 00763000430559
• UDI-Public: 00763000430559
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CB1812050120OTW
• Device Lot Number: 1143153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG