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

Catalog Number	CB1812050120OTW
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a percutaneous transluminal angioplasty procedure involving a chocolate 018 balloon during the advancement of the balloon into the lesion, deterioration was observed in the nitinol wires on the balloon, and resistance was encountered.The balloon was broken, there was damage to the wires on it.The procedure was conducted on a calcified lesion in the mid superficial femoral artery, which exhibited severe tortuosity and calcification, with a 95% stenosis over a length of 120 millimeters.The artery diameter was 5 millimeters, and a 6 french size sheath and guidewire were used.The device was prepped per the instructions for use, and no excessive force was applied.The faulty device was removed and replaced with a new packaged product, allowing the procedure to be completed successfully.
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.
Additional Manufacturer Narrative
Image analysis: one photo was received from the account.The image appears to show deformation to the mid and distal section of the balloon and cage.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.
Additional Manufacturer Narrative
Product analysis the returned device was inspected and no issue could be found with nitinol cage, ( 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 no issues found with the nitinol cage, the balloon was then inflated to rated burst pressure (rbp) of 12atms and no issues found with the nitinol cage.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: 20831395
• Report Number: 2183870-2024-00442
• Device Sequence Number: 8585537
• Product Code: LIT
• UDI-Device Identifier: 00763000500207
• UDI-Public: 00763000500207
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2025

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 Expiration Date: 07/25/2026
• Device Catalogue Number: CB1812050120OTW
• Device Lot Number: 1120323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: Not provided; 04/24/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/28/2025; 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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 Sex: Female