MAUDE Adverse Event Report: MEDTRONIC MEXICO EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,

Model Number	EUP2520X
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Device Damaged by Another Device (2915); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the device was returned for analysis.Blood was evident inside the balloon.Severe deformation was evident to the balloon with balloon material torn and peeled distally.Deformation was evident to the tip.It was not possible to pressurize the balloon due to the deformation.No other deformation was 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that a balloon leak occurred on one euphora coronary balloon catheter.The device was being used in a non-tortuous lesion in the mid circumflex (cx) artery.The device was being used to pre-dilate the lesion.The device was inspected prior to use with no issues noted.Negative prep was performed prior to insertion into patient with no issues.The balloon was then inserted into the patient and once the balloon presented outside the 6f launcher guide catheter it was noticed that the balloon looked different, and was 'shredded' in appearance, but proceeded to the lesion.There was no resistance noted when inserting the balloon inside the launcher guide catheter.Other accessory devices were not inside the launcher device when the balloon was being advanced.An attempt was made to inflate the balloon inside the patient to 12 atm, but the balloon would not hold.There were inflation difficulties.A burst did not occur.The issue occurred on the first attempted inflation.The device was not moved or repositioned while inflated.A saline and contrast solution was used.The balloon was removed without issues.It is not believed that the launcher caused or contributed to the damage on the balloon.The patient is alive.No patient complications have been reported as a result of this event.

• Brand Name: EUPHORA RX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22157039
• Report Number: 9612164-2025-02763
• Device Sequence Number: 15295974
• Product Code: LOX
• UDI-Device Identifier: 00643169560031
• UDI-Public: 00643169560031
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 06/06/2025

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 Expiration Date: 04/01/2026
• Device Model Number: EUP2520X
• Device Catalogue Number: EUP2520X
• Device Lot Number: 228571340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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
• Patient Age: 80 YR
• Patient Sex: Female