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

Catalog Number	A35HPV08080080
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	04/09/2024
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 9fr sheath and an 035 non-medtronic (boston superstiff amplatz) guidewire during a cholangiography procedure 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.The device did not pass through a previously deployed stent.No resistance was noted during advancement.Excessive force was not used.According to the end-user record, a balloon with a diameter size of 8mm was intended to be utilized but there seems to be a discrepancy between the size indicated on the package (8mm) and the actual size (5mm) perceived during the procedure.The physician compared the 9f sheath (3.33mm) and fortrex expected size (8mm x 80mm), the balloon was fully inflated at rated burst pressure but only showed up to 5.13mm on the image.Physician suspects it is a potential mislabelling.The procedure was completed using the 5mm balloon and patient was discharged.No patient injury reported.
Additional Manufacturer Narrative
Image analysis: the customer returned one procedural image.The image shows an inflated balloon in the patient¿s vasculature.There is a balloon outer diameter measurement of 5.14mm and an outer diameter measurement of 3.33mm for the distal end of a sheath 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: 19258836
• Report Number: 2183870-2024-00153
• Device Sequence Number: 6519877
• Product Code: LIT
• UDI-Device Identifier: 00763000106225
• UDI-Public: 00763000106225
• 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: 05/21/2026
• Device Catalogue Number: A35HPV08080080
• Device Lot Number: B567632
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/14/2024
• Date Device Manufactured: 05/20/2023
• 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
• Patient Sex: Unknown