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

Catalog Number	AB14W040120150
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
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 a procedure involving the percutaneous transluminal angioplasty nanocross 014 balloon, deflation and inflation difficulties occurred.The balloon catheter experienced deflation difficulties and slowed inflation.The balloon was not fully deflated and was removed with difficulty.The procedure was completed using a new device, which was not a medtronic device.The event occurred in the right superficial femoral artery, mid-location, with a lesion length of 120mm and an artery diameter of 5.1mm.The sheath used was a non-medtronic 6f, and the inflation device was a non-medtronic device with 50/50 contrast fluid.The instructions for use were followed without issue.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: pressure inflation issue was noted was during deflation.No leaks noted on the device and no reported damage to balloon catheter.No intervention was required to remove the balloon from catheter and the device was safely removed from the patient, no injury to the patient but the sheath was damaged in the process.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 with the balloon in a post-inflated state, a visual inspection of the device found that the balloon bond and the distal end of the outer shaft were stretched and kinked, the device was flushed and a 0.014¿ guidewire was loaded, an indeflator with pressure gauge was used to pressurise the balloon to its nominal pressure of 8atms but the balloon would not inflate, most likely due to the stretching and kinks the indeflator was then pressurised to its rated burst pressure (rbp) of 14atms balloon but the balloon would not inflate, most likely due to the stretching and kinks, 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: 21397694
• Report Number: 2183870-2025-00087
• Device Sequence Number: 9208299
• Product Code: LIT
• UDI-Device Identifier: 00763000757984
• UDI-Public: 00763000757984
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 03/18/2025

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: AB14W040120150
• Device Lot Number: B804246
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 02/25/2025; 03/14/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/13/2025; 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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
• Patient Sex: Male