MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Catalog Number	AB35W10060135
Medical Device Problem Codes	Burst Container or Vessel (1074); Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
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
It was reported that during procedure using the evercross balloon, the patient was diagnosed with iliac artery sclerosis and occlusion.Angiography confirmed iliac artery stenosis with 80% lesion stenosis in the proximal common iliac artery.The percutaneous transluminal angioplasty balloon dilatation catheter was used for dilatation, and the balloon was inflated to the rated standard pressure.However, the balloon was withdrawn and it was found it did not deflate well.After withdrawing the balloon, blood was found inside the balloon, indicating a rupture.The balloon was replaced, and the procedure was successfully completed.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis the device was returned with the balloon in a pre-inflated state, the device was flushed, and an 0.035¿ guidewire was loaded, the balloon was then inflated to its nominal pressure of 7atms, and its rated burst pressure (rbp) of 11atms, without any issues.The balloon was then fully deflated without any issues, 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: EVERCROSS 035
• 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: 21741383
• Report Number: 2183870-2025-00146
• Device Sequence Number: 18340474
• Product Code: LIT
• UDI-Device Identifier: 00763000185039
• UDI-Public: 00763000185039
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082579
• 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): 05/06/2025

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: AB35W10060135
• Device Lot Number: B661093
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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: Male