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

Catalog Number	A35HPV06080135
Medical Device Problem Codes	Burst Container or Vessel (1074); Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a percutaneous transluminal angioplasty draining vein procedure with a fortrex 6.0mmx80mm balloon, inflation was performed to a pressure of 23 atm.The balloon was suddenly deflated and the pressure indicator dropped to zero.Blood was aspirated from the balloon inflation tube.Upon removal, a rupture was found in the distal tip of the balloon.Visual inspection confirmed the rupture.The device was prepped per the ifu.No abnormalities reported in relation to anatomy.No patient complications or injury have been reported as a result of this event.
Additional Manufacturer Narrative
Image analysis the customer returned three images.Image 1 shows a carton label.The label shows that this is a fortrex 6 x 80mm (a35hpv06080135), lot #: b711028.Images 2 and 3 shows the balloon of a fortrex device.The images do not show any burst on the balloon.Product analysis # the device was returned with the balloon in a post-inflated state, (photo 3).The device was flushed, (photo 4) and a 0.035¿ guidewire was loaded, an indeflator with pressure gauge was used to inflate the balloon and water leaked out through a hole on the distal end of the balloon, 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: 24701277
• Report Number: 2183870-2026-00137
• Device Sequence Number: 15996528
• Product Code: LIT
• UDI-Device Identifier: 00763000634537
• UDI-Public: (01)00763000634537(17)270327(10)B711028(20)04
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 03/26/2026

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: A35HPV06080135
• Device Lot Number: B711028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male