MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV NC EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,

Model Number	NCEUP3527X
Medical Device Problem Codes	Deflation Problem (1149); Detachment of Device or Device Component (2907); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
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  with one nc euphora rx coronary balloon catheter, deflation difficulties occurred.The balloon failed to deflate in the mid right coronary artery (rca) which exhibited severe calcification, mild tortuosity and 99% lesion stenosis.The device was inspected  prior to use with no issues noted.The device did not pass through a previously deployed stent.As a result of the deflation difficulties, the patient required a coronary artery bypass surgery of the rca. no further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: it was not difficult to remove the protective sheath/stylette.Resistance was not noted while advancing the device to the lesion.The balloon had been inserted before, but not inflated and then reinserted for intervention.Difficulties were not noted during inflation of the device.An inflation pressure of 12 atmospheres one time, 14 atmospheres two times, and 16 atmospheres four times had been applied for each inflation.The device was not moved or repositioned while inflated.A concentration of 50/50 contrast / saline was used.The balloon was successfully removed during cardiac surgery.The open heart surgery was safely completed and the patient was discharged.Correction: phone number.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
Correction: imf code.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
Additional information: the balloon was being used to pre-dilate the lesion prior to stent deployment.The balloon had been initially inserted, but not inflated as it would not reach the mid rca so it was removed.The lesion was pretreated with a smaller 2.0 medtronic balloon with no issues noted.Then the 3.0 nc euphora balloon was reinserted for intervention in the rca and successfully reached the mid-rca.Deflation difficulties were noted when the balloon was reinserted and inflated after the 7th inflation.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
Additional information: the proximal portion of the balloon catheter was able to be removed, however the distal portion of the catheter had to be removed surgically.Product analysis: the device returned with the distal shaft and balloon detached at the exchange joint.The distal shaft and balloon did not return.The proximal shaft that returned exhibited stretching.The deflation difficulties could not be confirmed.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 ; 091708096
• MDR Report Key: 23654249
• Report Number: 9617601-2025-03020
• Device Sequence Number: 4824067
• Product Code: LOX
• UDI-Device Identifier: 00643169396319
• UDI-Public: (01)00643169396319(17)261105(10)230042891
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/27/2026

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: NCEUP3527X
• Device Catalogue Number: NCEUP3527X
• Device Lot Number: 230042891
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: Not provided; 12/05/2025; 01/07/2026; 02/09/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/04/2025; 12/18/2025; 01/28/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 123 KG