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

Catalog Number	AB14W040080150
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
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 a percutaneous transluminal angioplasty using the nanocross 014 balloon catheter in the left superficial femoral artery (mid and distal segments) of a patient with, severe calcification and a chronic total occlusion in a short segment with 80-90% stenosis in the remaining segment were present.The lesion measured 120 mm in length with a vessel diameter of 5 mm.Minimal resistance was encountered when advancing the device, and the vessel was pre-dilated with a nano 4/80 device.Deflation difficulties were noted with the balloon catheter; the balloon was inflated to 18 atm and then rapidly deflated to 4 atm, with no contrast observed in the inflator.The balloon required multiple inflations and deflations with saline to thin the contrast mix, and the balloon and sheath were eventually pulled out of the body after approximately 10 minutes.The balloon was inflated with what they believe to be a 70/30 contrast to saline mix.Because the contrast amount was too much it is believed that this caused the issue with deflation.The device was safely removed, and the procedure was completed using a new device.No patient complications have been report ed as a result of this event.
Additional Manufacturer Narrative
Image analysis three still angiogram images were provided for review.The images are photos of still angiogram images on a screen and are poor quality.The first image (3659) shows contrast enhanced view of the mid left superficial femoral artery with an unevenly expanded stent implanted.There is diffuse calcification and the distal portion and mid/proximal portion of the stent appears to be narrowed.There is a short segment dissection just proximal to the stent which is not flow limiting.There also appears to be contrast extravasation in the mid portion of the sfa.The second image (3660) demonstrates the angioplasty balloon enhanced with contrast and inflated in the sfa, the balloon appears unevenly inflated, and this appears to be prior to stenting.The third image (3658) demonstrates non-contrast enhancement of the sfa with visualization of the unevenly expanded stent.Product analysis the device was returned loaded into an introducer sheath.The balloon is detached, the inner shaft is stretched and the markerbands are still present, the balloon was detached at the balloon bond, 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: 24519505
• Report Number: 2183870-2026-00096
• Device Sequence Number: 9724709
• Product Code: LIT
• UDI-Device Identifier: 00763000757946
• UDI-Public: (01)00763000757946(17)280214(10)C045512(20)06
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/01/2026

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: AB14W040080150
• Device Lot Number: C045512
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2025
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 94 KG