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

Catalog Number	A35HPV07100080
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
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
Physician attempted to use a fortrex hp pta balloon catheter with a 7fr non-medtronic sheath and a 0.035 non-medtronic guidewire during treatment of a fibrous lesion in the patients left mid brachial artery (arteriovenous fistula).Moderate vessel tortuosity and moderate vessel calcification were reported.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.No issues were noted when removing the device from the hoop/tray.The device was prepped per the ifu (instruction for use) with no issues identified.Embolic protection was not used.A medtronic everest 30 inflation device was used.Saline inflation fluid was used.The device was not passed through a previously deployed stent.No resistance was encountered when advancing the device.A pin hole balloon leak was noted during balloon inflation at 20 atms.The balloon did not detach during event.Another brand of balloon was used to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Product analysis: the device was returned with the balloon in a post-inflated state.The device was flushed, and a 0.035¿ guidewire from the lab was loaded through the tip and exited through the luer.The balloon was inflated to its rated burst pressure (rbp) of 20atms but the balloon could not hold pressure.A visual inspection found water leaking out through the inner lumen/tip indicating a leak between the inner and outer lumen.Image analysis: the customer returned two device images and one procedural image.Images 1 and 2 show the inflated balloon.There is no evidence of a leak.Image 3 shows a procedural image of the inflated balloon in the patient¿s vasculature.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
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: 19927465
• Report Number: 2183870-2024-00239
• Device Sequence Number: 14148657
• Product Code: LIT
• UDI-Device Identifier: 00763000634674
• UDI-Public: 00763000634674
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,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: A35HPV07100080
• Device Lot Number: B694427
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/27/2024; 02/11/2025
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/11/2024; 03/06/2025
• Date Device Manufactured: 02/19/2024
• 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 Sex: Female