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

Catalog Number	A35HPV08040135
Medical Device Problem Codes	Nonstandard Device (1420); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
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
A physician used a fortrex hp pta balloon with a 6fr sheath and an 035 non-medtronic guidewire during treatment of the patients biliary artery.There were no abnormalities reported in relation to anatomy.Embolic protection was not used.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 ifu was followed and the device was prepped with no issues noted.A non-medtronic inflation device was used, connected as per ifu with a 50% contrast 50% saline used.The device did not pass through a previously deployed stent.No resistance was noted during advancement.Excessive force was not used.It was reported an 8mm balloon was utilized, but there seemed to be a discrepancy between the size indicated and the actual size perceived (6mm).Physician inflated balloon up to 20atm but still did not reach the size of 8mm.The device was safely removed from the patient.Patient already discharged.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.A 0.035¿ guidewire was loaded, and the balloon was inflated to its nominal pressure of 9atms, and the approximate balloon outer diameter was measured as 7.3mm along the balloon length.The balloon was then inflated to its rated burst pressure (rbp) of 20atms, the approximate balloon outer diameter was measured as 7.8mm along the balloon length.The balloon outer diameter measurements on the device returned for evaluation were within spec per the device label.Image analysis: the customer returned four procedural images.The images show an inflated balloon in the patient¿s vasculature.There are various balloon outer diameter measurements ranging from 6.4mm to 6.8mm marked on the image.Measurements taken are perceived and not measured by a calibrated measurement device.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: 19401008
• Report Number: 2183870-2024-00172
• Device Sequence Number: 8321973
• Product Code: LIT
• UDI-Device Identifier: 00763000106201
• UDI-Public: 00763000106201
• 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
• Report Date (Section B): 06/14/2024

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: 11/20/2025
• Device Catalogue Number: A35HPV08040135
• Device Lot Number: B481221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/27/2024
• Supplement Report FDA Received Date: 06/14/2024
• Date Device Manufactured: 11/21/2022
• 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 Sex: Unknown