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

Model Number	EUP2515X
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure involving one euphora balloon catheter, resistance was encountered when advancing the device, and the catheter stretched due to getting stuck on the non-medtronic wire.The device was described as very tacky when loading onto the wire, despite proper preparation.Once the euphora was inside the body, an attempt to move the device forward resulting in resistance, and upon pulling it back, it got stuck on the wire, causing the catheter to stretch.The device was subsequently removed.It was not difficult to remove the protective sheath or the packaging stylette.The device was inspected prior to use with no issues, and negative prep was performed successfully.The guidewire lumen in the balloon device was flushed before use.The lesion was not pre-dilated.There was no excessive force used during delivery.The device did not pass through a previously deployed stent.The guidewire was examined and flushed before use with no issues or kinks noted.The guidewire was being back loaded through the tip.Other balloons had been used previously on the wire without issues.The patient is alive with no injury.
Additional Manufacturer Narrative
Product analysis: stretching, kinking and deformation were evident to distal shaft and core wire.A detachment of the core wire was evident however the wire did not protrude through the outer shaft.It remained within the inflation lumen with no risk of sharp edges.Bunching and flattening were evident to the inner member.Deformation was evident to the distal tip.A 0.014 inch guidewire could not be loaded through the device due to the deformation to the device.No other deformation 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; 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: 21434073
• Report Number: 9612164-2025-00967
• Device Sequence Number: 20010622
• Product Code: LOX
• UDI-Device Identifier: 00643169560024
• UDI-Public: 00643169560024
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/21/2025

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: 09/19/2026
• Device Model Number: EUP2515X
• Device Catalogue Number: EUP2515X
• Device Lot Number: 229717830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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: 62 YR
• Patient Sex: Male