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

Model Number EUP2515X

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2024

Event Type  malfunction  

Event Description

An attempt was made to use one euphora rx balloon catheter to treat a lesion during a coronary angioplasty procedure.It was reported that there was difficulty removing the balloon catheter following balloon inflation.It was detailed the balloon catheter was correctly positioned and inflated.However, the balloon did not deflate after the expected dilation time and removal difficulties were encountered.It was also noted that the catheter/delivery system was deformed.No 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

Product analysis summary: the device returned to medtronic for evaluation.A kink was evident to the hypotube.The balloon was deflated on device return with balloon folds expanded.Contrast was visible in the balloon.No necking was evident to the proximal bond or inflation lumen.Stretching evident to the guidewire lumen.The balloon passed negative prep.The balloon was inflated to 8 atms, and deflation testing was completed without issue.No other deformation was evident to the remainder of the device.Additional information it was not difficult to remove the protective sheath.It was not difficult to remove the packaging stylette.The device was inspected before use with no issues noted.A 50/50 concentration of contrast/saline was used.Resistance was not noted while advancing the device to the lesion.Excessive force was not used.The device was being used on the trapping balloon technique.The balloon was not used on a coronary stenosis.The balloon was inflated in the guide catheter.There were no difficulties noted during inflation of the device.Deflation difficulties were noted after the first inflation.The balloon failed to deflate.It was also noted that the catheter/delivery system was deformed after the removal.The balloon was removed from the patient by pulling it back with no difficulty experienced.No intervention was required to remove the device from the patient.The device was not moved or repositioned while inflated.There was no injury to the patient as a result of the event.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
• 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: 18678416
• MDR Text Key: 335030537
• Report Number: 9612164-2024-00718
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K143480
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EUP2515X
• Device Catalogue Number: EUP2515X
• Device Lot Number: 226365766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2023
• 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