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

Model Number NCEUP4512X

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Entrapment of Device (1212); Inflation Problem (1310); Leak/Splash (1354); Difficult to Remove (1528); Component Missing (2306); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/09/2023

Event Type  Injury  

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.

Event Description

An attempt was made to use one nc euphora rx balloon catheter to treat a moderately tortuous, non-calcified lesion in the proximal right coronary artery (rca).The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device passed through a previously deployed stent.No resistance was felt or no excessive force was used when deploying the balloon.It was reported that the balloon catheter failed to deflate after the first inflation.During post dilation of a deployed non-medtronic stent, the nc euphora was inflated at 20atm at the proximal rca.It was detailed that the proximal shaft unexpectedly inflated.It was suspected that this was due to the continuous system of balloon.Balloon deflation was immediately attempted.However, the balloon failed to deflate and the proximal shaft remained inflated.The balloon was attempted to be removed, but it got stuck in the inlet of the 6f guide catheter.As a result, the entire system including guide wire and guiding catheter were removed from the femoral artery.The patient is alive with no injury.

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: the lesion had 70% stenosis.It was not difficult to remove the protective sheath or the packaging stylette.From the angiographic video a balloon burst was not suspected to have occurred, however a catheter leak did occur.It was suspected that this was due to the continuous system of the balloon, meaning there may be an area that is not enclosed properly, leading to proximal shaft inflation.A detachment wasn't noticed, however it is suspected that any detached portion was stuck in the sheath used for femoral artery access.An attempt was initially made to try and extract the balloon, guide catheter, and guidewire as a whole.However, the balloon was stuck at the sheath's haemostasias valve.In response, it was decided to use an introducer to open up the valve to extract the defected balloon.This may have led to the removal of the detached portion, but this cannot be clarified.The device was not moved or repositioned while inflated.The device was not kinked and re-straightened during use.A 1:1 ratio of contrast / saline concentration was used.The same inflation device was successfully used with other devices.The guide catheter used was a medtronic 6f launcher device.The guidewire was a non-medtronic device.Initial reporter phone number.Product analysis: the device was returned for analysis.Upon return it was noted that a portion of the outer shaft, proximal to the balloon and proximal balloon bond had expanded and appeared to have burst.The material was jagged and uneven at the burst site.The balloon and the outer shaft material, distal to the expansion site had detached exposing the inner member underneath.The detached material did not return.The length of the exposed inner member was stretched and kinked.The distal marker band was missing, and the proximal marker band was flattened.The tip was stretched and part of it had detached.The shaft, proximal to the burst site was kinked.It was not possible to perform inflation/deflation/leak testing due to the condition of the returned device.No other damage noted to the remainder of the device.Image analysis: a video was provided from the account showing the pressurization of the balloon at the lesion site.As the catheter continued to be pressurized a portion of the shaft proximal to the balloon and the proximal balloon bond area expanded and filled with contrast.Further pressurization of the catheter resulted in the damaged catheter shaft material bursting with contrast escape into the vessel.From these images it appears that a previously damaged portion of the distal inflation lumen outer shaft resulted in the expansion of the shaft at that point.Further pressurization resulted in a burst of the shaft.The balloon appears to remain intact and has not burst.Image analysis: one photo received from the account.Detachment of the distal tip visible with the distal marker band missing.A video 0582.Mov, was provided from the account.A still image from the video shows the distal marker band was missing.Another still image from the video shows a burst outer shaft leaving the length of the inner member exposed stretched and kinked.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.

• 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: 17331754
• MDR Text Key: 319809006
• Report Number: 9612164-2023-03209
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NCEUP4512X
• Device Catalogue Number: NCEUP4512X
• Device Lot Number: 226000139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• 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): Other; Required Intervention