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

Catalog Number	A35HPV06040080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/14/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during a percutaneous transluminal angioplasty procedure using the fortrex balloon dilatation catheter at the distal left arteriovenous fistula anastomosis between the artery and cephalic vein, a 60% soft tissue lesion stenosis was present.During balloon inflation with an inflation device at 23 atm, a pin hole rupture of the balloon occurred, resulting in a balloon burst.All fragments of the balloon were retrieved.Subsequently, an arteriovenous endoleak and fistula arteriovenous vessel rupture occurred, which was addressed by performing a vascular anastomosis.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information patient status is safe, with no complication.Image analysis all three images depict the fortrex and what appears to be a longitudinal burst can be observed on 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: 22402406
• Report Number: 2183870-2025-00351
• Device Sequence Number: 21280968
• Product Code: LIT
• UDI-Device Identifier: 00763000105983
• UDI-Public: (01)00763000105983(17)261025(10)B645815
• 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,Followup
• Report Date (Section B): 07/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A35HPV06040080
• Device Lot Number: B645815
• 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: 06/15/2025
• Supplement Date Received by Manufacturer: 07/13/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 07/29/2025
• Date Device Manufactured: 10/26/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 75 KG