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

Model Number	EUP3512X
Medical Device Problem Codes	Deflation Problem (1149); Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	04/06/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that during a procedure involving a euphora balloon rx, the device became stuck in the inflated position within the left main to circumflex artery.The complication arose during final post-dilatation of stents in the left main coronary artery extending into the left circumflex artery, when a 3.5x15 mm non-medtronic nc balloon fractured.The distal (monorail) opaque tip separated from the hypotube and remained within the coronary artery, stuck in the previously implanted stent in the left main to the circumflex artery.Multiple unsuccessful attempts were made to retrieve the fractured non-medtronic balloon.During efforts to retrieve the non-medtronic device, a euphora balloon rx was introduced and subsequently became stuck in the same segment, also in the inflated position.An attempt was made to deflate the euphora balloon by cutting the shaft, but this was unsuccessful.Several additional retrieval efforts failed.The patient was ultimately referred for surgical intervention for potential device retrieval and coronary artery bypass grafting (cabg).
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.
Additional Manufacturer Narrative
Additional information: the lesion being treated was very calcified, at a 90 degree angle, bifurcated and had 90% stenosis.It was not difficult to remove the protective sheath or the packaging stylette.The euphora device was inspected before use with no issues noted.Resistance was not noted while advancing the device to the lesion.A concentration of 30/50 contrast/saline was used.The previously implanted stents were non-medtronic devices.There were no difficulties noted during inflation of the device.Four inflations were performed prior to the deflation difficulties.Inflation pressures of 15, 19, 18, and 12 atm were applied, respectively, for each inflation.The device was moved or repositioned while inflated.The balloon failed to deflate.The detached portion of the euphora device was not successfully removed from the patient.The cabg was successfully performed but with the balloon still in the patient anatomy.The patient later passed away.Device lot number provided.Patient weight provided.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: annex d 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.

• 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: 22037070
• Report Number: 9612164-2025-02447
• Device Sequence Number: 12849837
• Product Code: LOX
• UDI-Device Identifier: 00643169560277
• UDI-Public: (01)00643169560277(17)260827(10)229541903
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2025

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 Expiration Date: 08/27/2026
• Device Model Number: EUP3512X
• Device Catalogue Number: EUP3512X
• Device Lot Number: 229541903
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 08/15/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/24/2025; 08/18/2025
• Date Device Manufactured: 08/27/2024
• 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: Death; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 80 KG