MAUDE Adverse Event Report: Medtronic Mexico S. de R.L. de CV NC EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,

Model Number	NCEUP4512X
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure involving one nc euphora coronary balloon, a balloon rupture occurred during balloon inflation.The lesion being treated was non tortuous, non calcified with 90% stenosis in the proximal right coronary artery (rca).The device was inspected before use with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device.The nc euphora balloon was inflated once at 14atm for 10 seconds in the proximal rca lesion for post dilation of the stent when it ruptured.The nc euhpora was pulled back into the right radial artery for removal.However difficulties were encountered removing the device.The device would not fit through the 6f radial sheath.It was attempted to pull the wire and guide out with balloon/catheter inside.However, the distal end/balloon tip of the nc euphora balloon then fractured off and became dislodged in the patients radial artery.As a result, the patient was sent to vascular surgery for removal and further vessel injury.The detached part of the device was successfully removed.The patient was discharged 6 days later and went home in good recovery.The patient was reported to be alive with injury.No further patient complications were reported as a result of the 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.

• Brand Name: NC EUPHORA RX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
• Manufacturer (Section D): Medtronic Mexico S. de R.L. de CV; av. paseo cucapah 10510 el lag; tijuana baja california,mx 22570 ; MX 22570
• Manufacturer (Section G): Medtronic Mexico S. de R.L. de CV; av. paseo cucapah 10510 el lag; tijuana baja california,mx 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50867418
• Report Number: 9617601-2026-05743
• Device Sequence Number: 10674472
• Product Code: LOX
• UDI-Device Identifier: 00643169396173
• UDI-Public: (01)00643169396173(17)280721(10)234279400
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• 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): 09/23/2026

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 Model Number: NCEUP4512X
• Device Catalogue Number: NCEUP4512X
• Device Lot Number: 234279400
• 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: 09/16/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 07/22/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 193 LB