MAUDE Adverse Event Report: COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Catalog Number	A35HPV06100135
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a percutaneous transluminal angioplasty procedure using a fortrex balloon, there were difficulties inflating the balloon, due to a balloon leak.Additionally, there were issues with poor guidewire movement, difficulties loading or exchanging the guidewire, and resistance encountered when advancing the device.The procedure involved the right radial artery, specifically targeting a proximal fibrous lesion with 90% stenosis, moderate tortuosity, and little calcification.The artery diameter was 2.1 millimeters, and the lesion length was 5 millimeters.The balloon was inflated using an inflation device at a pressure of 12 atm, and the device passed through a previously-deployed stent.The procedure was completed by replacing the percutaneous transluminal angioplasty balloon.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
One photo was received from the account.The image appears to show a coiled catheter in a plastic bag.The balloon is not visible in the image.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: FORTREX 0.035 OTW PTA BALLOON CATHETER
• 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: 21409811
• Report Number: 2183870-2025-00090
• Device Sequence Number: 9518561
• Product Code: LIT
• UDI-Device Identifier: 00763000106058
• UDI-Public: 00763000106058
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142654
• 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
• Report Date (Section B): 02/19/2025

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: 06/23/2025
• Device Catalogue Number: A35HPV06100135
• Device Lot Number: B405623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/19/2025
• Date Device Manufactured: 06/24/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 56 KG