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

Catalog Number NCEUP5012X

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Material Deformation (2976)

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

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An attempt was made to use an nc euphora balloon catheter.It was reported that inflation difficulties were encountered.During balloon inflation the shaft of the device burst.The shaft of the device prior to the burst was described as appearing like a second balloon due to the expansion of the shaft.No patient injury was reported.

Manufacturer Narrative

Additional information: a video file was provided for review.The distal section of the device was observed in the video.The balloon appeared to inflate and a section of the mid distal shaft appeared to inflate and then burst.Liquid was observed exiting through the burst material on the distal shaft.The device was being used to treat a non-calcified, non-tortuous lesion with 95% stenosis in the ostium of the left main coronary artery.The device was being used to post dilate a deployed non-medtronic stent.There was no damage noted to the device packaging.There were no issues noted removing the device from the packaging.No difficulties were encountered when removing the device protection.The device was inspected with no issues noted.Negative prep was performed with no issues.Force was not used when loading the device on the wire.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.No other devices were in the guidewire during delivery.It was then reported that the balloon did not deflate following first inflation at 18-20 atm.After 4-5min the patient was decompensating, and the pressure was intentionally increased to 30atm to burst the balloon.The device was completely removed from the patient body, without any intervention.When removing the balloon the non-medtronic stent moved from the implanted site.No additional intervention was required for the migrated stent.The patient was discharged.Patient age, gender, weight provided (a2, a3, a4) 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: balloon folds expanded on device return.The device failed negative prep.Inflation testing was not completed.Upon visual inspection of the device, there was a tear was identified to the inflation lumen.The inflation lumen material was jagged and uneven at the tear site.No deformation evident to the distal tip.No other damage evident to the remainder of the 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.

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: images provided depict procedures in the right coronary artery (rca) and in the left main (lm) artery.The rca appears to have been treated first.A stenotic lesion can be observed at the ostium of the rca.Successful pre-dilation of the lesion, delivery and deployment of a stent and post-dilation of the stent can be observed.Improved blood flow can be observed in the rca.Following treatment of the rca a lesion in the ostium of the left main (lm) artery.Attempted delivery and inflation of multiple balloons can be observed.Several consecutive image sets captures a balloon that appears to be inflated over 3 minutes, and deflation cannot be observed.Following a two minute gap an uninflated balloon can be observed.It is possible that the reported deliberate burst of the balloon occurred during this gap in the images that were provided.Following a further 9 minute gap in the images, delivery, deployment and post-dilation of a stent can be observed.Following a further ten minute gap the deployed stent can be observed.It is possible that the reported deflation difficulties and deliberate burst occurred in during the gap in the images, however this cannot be confirmed.The difficulties that were reported were not captured on the film image provided, the reported stent migration cannot be observed.Improved blood flow can be observed in the lm artery.Patient date of birth 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.

• 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: 12974245
• MDR Text Key: 287026494
• Report Number: 9612164-2021-04794
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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,Followup,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Catalogue Number: NCEUP5012X
• Device Lot Number: 222338965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• 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: 25 YR
• Patient Sex: Female
• Patient Weight: 48 KG