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

Model Number	NCEUP2512X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure involving one nc euphora balloon catheter deflation difficulties were encountered.The device would not deflate at the lesion site.The lesion being treated was a severely calcified, moderately tortuous lesion with 99% stenosis in the mid circumflex (cx) artery.The device was inspected prior to use with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device and excessive force was not used during delivery.During pre-dilation of the severe mid cx lesion with severe calcification, the balloon would not deflate.After several attempts of deflation with a suction syringe, the balloon was removed through the guide and sheath.Rewiring was done and the pci was completed.No further patient complications were reported as a result of this 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: 50896651
• Report Number: 9617601-2026-05787
• Device Sequence Number: 21510770
• Product Code: LOX
• UDI-Device Identifier: 00643169395930
• UDI-Public: (01)00643169395930(17)280712(10)234220215
• 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): 09/25/2026

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: NCEUP2512X
• Device Catalogue Number: NCEUP2512X
• Device Lot Number: 234220215
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 07/13/2026
• 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
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 131 LB