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

Model Number NCEUP37512X

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); Insufficient Information (4580)

Event Date 10/09/2023

Event Type  Injury  

Event Description

An attempt was made to use one nc euphora balloon catheter to treat a lesion.It was reported that balloon deflation difficulties were encountered and the device would not deflate at the lesion site. it was detailed that despite various efforts to deflate the balloon catheter, it remained inflated.There was difficulty removing balloon and it was noted that the consultant was reluctant to cut the catheter.It was then deflated.No further patient injury was reported.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: an attempt was made to use one nc euphora balloon catheter to treat a lesion located in the left anterior descending (lad) artery / main stem.The device was inspected before use with no issues noted.No difficulties noted to remove the protective sheath.No difficulties noted to remove the packaging stylette.A 50mls of contrast to 40mls of saline was used.The inflation pressure applied to each inflation was 12 atm.One inflation was performed prior to the deflation difficulties.There was no difficulties noted during inflation of the device.Deflation difficulties were noted after the first inflation.The balloon failed to deflate.Resistance was not noted while advancing the device to the lesion. the balloon was inflated to 24 atm and while giving negative pressure, the balloon either ruptured or finally deflated.There was difficulty removing the balloon and it was noted that the consultant was reluctant to cut the catheter.The catheter was not cut.The balloon was pulled into the guide when the balloon was still inflated and disengaged from the main stem with no issues noted.It was then deflated.The device was not moved or repositioned while inflated.Intervention was not required to remove the device from the patient.The patient suffered chest pains and there was st changes noted on e lectrocardiogram (ecg).Lot number provided.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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
• Type of Device: 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: 18356764
• MDR Text Key: 330891749
• Report Number: 9612164-2023-06067
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2024

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
• Device Operator: Health Professional
• Device Model Number: NCEUP37512X
• Device Catalogue Number: NCEUP37512X
• Device Lot Number: 226332947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/18/2024; 04/15/2024
• Supplement Dates FDA Received: 02/01/2024; 04/15/2024
• Date Device Manufactured: 04/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention