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

Model Number	NCEUP4512X
Medical Device Problem Codes	Deflation Problem (1149); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/26/2024
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
An attempt was made to use one nc euphora coronary balloon catheter to treat a non-calcified, soft lesion located in the right coronary artery (rca).The procedure was for an st segment elevation myocardial infarction (stemi).The device was inspected with no issues.Negative prep was performed with no issues noted.The balloon was being used to post dilate a stent.It was reported that balloon deflation difficulties occurred, and the device would not deflate at the lesion site.The nc euphora was blocking flow in the artery.The device was taken to the guide and then everything was pulled out of the artery together.Intravascular ultrasound (ivus) was used, and the stent was post dilated with another 4.5x12mm nc euphora balloon to 12 atm.The patient is alive with no further injury and is unharmed.
Additional Manufacturer Narrative
Additional information: the patient was admitted to the hospital with stemi.The lesion was non-tortuous with 80% stenosis.It was not difficult to remove the protective sheath or the packaging stylette.A 50-50 concentration of contrast/saline was used.A compliant balloon was first used with no issues noted.The device did pass through a previously deployed stent.Resistance was not noted while advancing the device to the lesion.The balloon failed to deflate.One inflation was performed prior to the deflation difficulties at 12 atm.No inflation difficulties were noted.The device was not moved or repositioned while inflated.There was no injury to the patient as a result of the balloon blocking flow, and no intervention was needed.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
Product analysis summary: the device returned to medtronic for evaluation.Stretching was evident to the distal shaft and inner member.Necking was evident to the proximal balloon bond and inner member.The balloon folds returned expanded.The distal marker band had moved position to the mid balloon position possible due to the stretching of the inner member.No deformation was evident to the distal tip.Deflation testing could not be carried due to the condition of the device.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.
Additional Manufacturer Narrative
Additional information: annex d code added.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: 19277775
• Report Number: 9612164-2024-02218
• Device Sequence Number: 6320258
• Product Code: LOX
• UDI-Device Identifier: 00643169396173
• UDI-Public: 00643169396173
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 06/21/2024

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: 09/17/2025
• Device Model Number: NCEUP4512X
• Device Catalogue Number: NCEUP4512X
• Device Lot Number: 227352304
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 05/10/2024; 05/30/2024; 06/18/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/27/2024; 06/11/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• 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: 58 YR
• Patient Sex: Male