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

Model Number	EUP2020X
Medical Device Problem Codes	Burst Container or Vessel (1074); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
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 one euphora rx coronary balloon catheter, the balloon burst during balloon inflation.The target lesion exhibited severe tortuosity, severe calcification and 99% lesion stenosis.The balloon ruptured during inflation while attempting to prepare the lesion for a larger balloon to cross.The device was inspected prior to use with no issues noted.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: the balloon burst during the first balloon inflation.The target lesion was located in the proximal popliteal artery.The device was being used to pre-dilate a lesion.Negative prep was performed with no issues noted.Resistance was not noted while advancing the device.The device was not moved or repositioned while inflated.Product analysis summary: the device was returned for evaluation.The device returned with the balloon in a post inflated state.The distal tip exhibited mild deformation.A longitudinal balloon burst was observed on the balloon material along the balloon working length.The balloon could not be pressurized due to the balloon burst.No other damage evident to the remainder of the device.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: 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: 24570620
• Report Number: 9617601-2026-01746
• Device Sequence Number: 15829282
• Product Code: LOX
• UDI-Device Identifier: 00643169559905
• UDI-Public: (01)00643169559905(17)271027(10)232582849
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143480
• 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
• Report Date (Section B): 05/14/2026

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 Model Number: EUP2020X
• Device Catalogue Number: EUP2020X
• Device Lot Number: 232582849
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 03/12/2026; 04/21/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/08/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2025
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 73 KG