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

Model Number EUP1512X

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 03/07/2024

Event Type  malfunction  

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 Description

An attempt was made to use one euphora coronary balloon catheter to treat a severely tortuous, severely calcified lesion with 100% chronic total occlusion (cto) in the mid circumflex (cx) artery.The device was inspected with no issues.Negative prep was performed with no issues.The device did not pass through a previously deployed stent.Excessive force was not used during delivery.It was reported that the balloon burst upon attempted inflation and dilation of the lesion.No adverse effect to the patient were reported.The patient is alive with no injury.

Manufacturer Narrative

Additional information: the device was being used to pre-dilate the lesion.The burst occurred on the first inflation.The device was not moved or repositioned while inflated.Product analysis: the device was returned for analysis.Kinks were evident to the hypo-tube.The device returned with balloon folds expanded.The balloon failed negative prep.On pressurization of the device, liquid was observed exiting the balloon working length.The balloon failed to maintain pressure.Upon visual inspection of the device, a short longitudinal tear was observed on the balloon material, on the balloon working length.Scratches were evident to the balloon.The balloon material was jagged and uneven at the tear site.Deformation was evident to the distal tip.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.

• 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: 18968865
• MDR Text Key: 338492653
• Report Number: 9612164-2024-01427
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169559837
• UDI-Public: 00643169559837
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EUP1512X
• Device Catalogue Number: EUP1512X
• Device Lot Number: 225901624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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