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

Model Number EUP27510X

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

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

Event Date 05/01/2023

Event Type  malfunction  

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.

Event Description

An attempt was made to use one euphora balloon catheter to treat a lesion.It was reported that a catheter leak/burst occurred, and there was a shaft issue.No patient injury reported.

Manufacturer Narrative

Additional information: the device was inspected before use.Negative prep was performed on the device prior to use with no issues noted.Resistance was noted while advancing the device to the lesion.Excessive force was not used.It was later confirmed that there was no device burst or leak.The balloon catheter shaft had a double bend upon removal from the hoop.It is not known why the device was attempted to be used after the double bend was noted on the balloon shaft during initial inspection.When attempting to advance the device through the guide catheter, too much resistance was felt so it was deemed that the balloon was not usable.The device never made it out of the guide catheter.The balloon was never inflated.The patient is reported to be well.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: the device was received for analysis.The device returned with kinks to the hypo-tube.A stop cock returned attached to the luer.The threads of the stop cock and the threads of the luer were not aligned this was evident as the stopcock and delivery system were stuck at a slight slant.Although the threads were not aligned, no other damage was noted to the threads.Numerous attempts were made to remove the stop cock by hand and using some pliers.All attempts were unsuccessful.The stop cock could not be removed.The balloon folds returned intact.On visual inspection of the device it seemed there was blood visible inside of the balloon.Resistance was felt when loading the device through an in-house guide catheter due to kinks on the hypo-tube.The luer was removed to pressurize the balloon using the standalone pressure gage.The balloon passed negative prep.The balloon was inflated to a nominal of 8 atm and maintained pressure.After inflation it was noted that the visible blood was on the balloon surface rather than inside the balloon.The shaft of the device was clamped with some pliers where the luer was removed.The stop cock and delivery system were then attached to the standalone pressure gage.The device was inflated to the rated burst pressure.The device-maintained pressure and no leak or burst was evident to the luer or stopcock.No other damage was noted to the stop cock of the luer.No other deformation evident to the remainder of the device.Additional information: the guide catheter being used during the procedure was a 6f launcher device.The launcher device has been used successfully with other devices prior to and after the difficulties occurring with the euphora device.The same launcher device was used with the replacement device.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.

• 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: 16901340
• MDR Text Key: 314893038
• Report Number: 9612164-2023-01957
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169560079
• UDI-Public: 00643169560079
• 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,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2024
• Device Model Number: EUP27510X
• Device Catalogue Number: EUP27510X
• Device Lot Number: 223703599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2022
• 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 Age: 56 YR
• Patient Sex: Male