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

Catalog Number	AB14W025120150
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis the device was returned with the balloon in a post-inflated state the device was flushed and a 0.014¿ guidewire was loaded an indeflator was used to inflate the balloon but it would not hold pressure.A pinhole leak was found on the balloon 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
A physician was attempting to use a nanocross pta balloon was intended to be use used for the treatment of a fibrous/plaque lesion with 70% stenosis in the mid/distal region of the left peroneal artery.The device was prepped as per the ifu with no issues identified.The balloon was inflated with a syringe, inflation fluid was used.No leaks noted on the device.It was reported during balloon inflation at 12atm balloon inflation difficulties were met, balloon could not be inflated.The device had not passed through a previously deployed stent and no resistance was met when advancing the device.Another balloon of the same model was used to complete the case.No patient injury.When the device was received for evaluation, it was noted that the there was a leak in the balloon.

• 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: 21400068
• Report Number: 2183870-2025-00083
• Device Sequence Number: 9345287
• Product Code: LIT
• UDI-Device Identifier: 00763000109684
• UDI-Public: 00763000109684
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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 Expiration Date: 02/19/2026
• Device Catalogue Number: AB14W025120150
• Device Lot Number: B521756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 02/18/2025
• Date Device Manufactured: 02/20/2023
• 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