MAUDE Adverse Event Report: COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Catalog Number	AB14W040150150
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a percutaneous transluminal angioplasty procedure using the nanocross 014, deflation difficulties occurred when the balloon would not deflate.A small kink in the catheter was noticed after removal.The procedure was aborted.The target lesion was located in the peripheral arteries, specifically the common iliac artery, superficial femoral artery, and popliteal artery, with an artery diameter of 6mm and calcification present.The vessel was pre-dilated and the device was passed through a previously deployed stent.The balloon was inflated using an inflation device, and deflation was attempted by snaring through a trailblazer.No abnormalities were reported in relation to anatomy, and instructions for use were followed without issue.No patient complications have been reported as a result of this event.
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.
Additional Manufacturer Narrative
Product analysis the device was returned stuck on a 0.014¿ guidewire, with the hub detached, the outer and inner shafts are stretched, and the balloon detached at the balloon bond, approximately 80mm of the detached balloon was returned, no functional testing could be carried out due to the condition of the returned 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: NANOCROSS 0.14 OTW PTA DILATATION 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: 23533172
• Report Number: 2183870-2025-00524
• Device Sequence Number: 9020930
• Product Code: LIT
• UDI-Device Identifier: 00763000758004
• UDI-Public: (01)00763000758004(17)270822(10)B778243(20)06
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K132777
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AB14W040150150
• Device Lot Number: B778243
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female