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

Model Number	NCEUP3015X
Medical Device Problem Codes	Burst Container or Vessel (1074); Deflation Problem (1149); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2025
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 one nc euphora coronary balloon, the device experienced balloon deflation difficulties and would not deflate at the lesion site.The lesion being treated was mildly tortuous, moderately calcified with 70% stenosis in the mid left anterior descending (lad) artery.The device was inspected prior to use with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.The nc euphora would not deflate and would not move inside the stent.Multiple techniques were attempted to try and move or deflate the balloon, but these efforts were unsuccessful.Ultimately, the balloon had to be burst as it would not deflate.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 or the packaging stylette.The device was being used to post-dilate a deployed stent.There were no difficulties noted during inflation of the device to nominal pressure.The deflation difficulties were noted after the first inflation.The balloon failed to deflate.Multiple techniques were attempted to try and move or deflate the balloon, including the use of three indeflators, but these efforts were unsuccessful.Ultimately, the balloon had to be burst by being inflated to 34 atm as it would not deflate to be removed from the patient.The device was not moved or repositioned while inflated.A concentration of 50/50 contrast/saline was used.Intervention was not required to remove the device from the patient.There was no injury to the patient as a result of the event.Product analysis: the device was returned for analysis.Kinks were evident to the hypo-tube.Balloon folds were expanded on device return.A burst was evident at the proximal bond with evidence of inflation at the burst site.It was not possible to perform deflation testing due to the burst.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.
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: NC 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: 21650618
• Report Number: 9612164-2025-01426
• Device Sequence Number: 15323486
• Product Code: LOX
• UDI-Device Identifier: 00643169395855
• UDI-Public: 00643169395855
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 06/05/2025

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 Model Number: NCEUP3015X
• Device Catalogue Number: NCEUP3015X
• Device Lot Number: 230496821
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 03/24/2025; 06/04/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/16/2025; 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male