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

Catalog Number	AB14W050200150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of a nanocross elite pta balloon catheter device, for the treatment of a calcified lesion in the proximal and mid section of the left superficial femoral artery, a pin-hole balloon burst (balloon burst at, below, or unknown rated burst pressure) occurred on the second inflation.The vessel was post-dilated with a (medtronic) 5 x 150 nanocross.The balloon did not pass through a previously deployed stent.No resistance was encountered when advancing the device.The balloon was inflated with a (merit medical) inflation device using 50/50 contrast fluid.No damage was noted to the packaging and no issues were noted when removing the device from the hoop/tray.The ifu was followed without issue.It is not known at what pressure the balloon burst.The balloon did not detach during the procedure.The device was safely removed from the patient.The procedure was completed using a new (medtronic) 5 x 150 nanocross device.The patient was reported as alive, with no injury.No injury or intervention was associated with this event.No health consequences or impact were reported as a result of this event.No patient symptoms or complications have been reported as a result of this event.A monarch inflation device was used.
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.

• Brand Name: NANOCROSS ELITE 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 ; +353(091)708096
• MDR Report Key: 50948212
• Report Number: 2183870-2026-00484
• Device Sequence Number: 9552504
• Product Code: LIT
• UDI-Device Identifier: 00763000758189
• UDI-Public: (01)00763000758189(17)290717(10)C364748(20)06
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082854
• 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
• Report Date (Section B): 09/30/2026

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: AB14W050200150
• Device Lot Number: C364748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 07/18/2026
• 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: Unknown