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

Catalog Number	A35HPV08040080
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to use a fortrex hp balloon prior to patient treatment.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 (instruction for use) was followed during pr eparation, procedure, post-procedure with an issue noted.50/50 contrast inflation fluid was used.It was reported a leak was noted during preparation.This issue is reported for 3 balloons.A replacement medtronic device was used to complete procedure.No patient involvement.
Additional Manufacturer Narrative
Product analysis: the device was returned with the balloon in a pre-inflated state.A visual inspection of the device found a hole on the shaft approximately 10mm from the strain relief.A 20mm water filled syringe w as connected and water leaked out through the hole.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: 19688612
• Report Number: 2183870-2024-00211
• Device Sequence Number: 7093755
• Product Code: LIT
• UDI-Device Identifier: 00763000106195
• UDI-Public: 00763000106195
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

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 Catalogue Number: A35HPV08040080
• Device Lot Number: B667276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 07/08/2024
• Date Device Manufactured: 12/11/2023
• 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