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

Catalog Number NCEUP3520X

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 07/26/2022

Event Type  Injury  

Event Description

An attempt was made to use one nc euphora device to treat a mildly tortuous, non calcified lesion with 99% stenosis in the proximal left anterior descending (lad) artery.The device was inspected before use with no issues noted, negative prep was carried out with no issues noted.Resistance was not encountered when advancing the device and excessive force was not used during delivery.The device did pass through a previously deployed stent.The lesion was pre-dilated with a euphora balloon, and a non medtronic stent was implanted.The distal portion of the stent was post dilated with a non medtronic nc balloon.The nc euphora device was then being used to post dilate the proximal portion of the deployed stent.It was reported that the balloon ruptured, however this did not cause a perforation to the vessel.Contrast was noticed going backward out of the balloon.It appeared that the balloon was not fully deflated.Several attempts were made to deflate the balloon with limited success.An attempt was made to retrieve the device inside the guide catheter however the nc euphora couldn¿t enter the guide catheter.After several attempts it was decided to retrieve the guide catheter and the balloon device as one unit however the balloon detached in the radial artery.Multiple attempts were made to retrieve the balloon from the radial artery with limited success.Firstly an attempt was made to try and pull the balloon inside the guide catheter.Secondly an attempt was made to retrieve the balloon by using a non medtronic guide extension catheter (gec).Thirdly an attempt was made to retrieve the balloon by inflating another balloon distally and try and remove both balloons together however this was also unsuccessful.Lastly an attempt was made to use a snare to retrieve the balloon.It was possible to retrieve the balloon from the proximal radial artery to the distal radial artery however the balloon got stuck within the tip of the sheath.Open surgical extraction was carried out to remove the balloon from the mid radial artery.The patient is reported to be alive with 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: d: lot number provided.It was not difficult to remove the protective sheath.It was not difficult to remove the packaging stylette.A 50/50 concentration of contrast /saline was used.An inflation pressure of 16 atm was applied prior to the balloon burst.No difficulties were noted during inflation of the device, but just few seconds after reaching the desired balloon atm the rupture was noticed and the contrast leak back (proximal).The device was not moved or repositioned while inflated.The patient's condition is reported to be good as the pci finished well and the balloon piece was removed by open wrist surgery.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: patient initials 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.

Manufacturer Narrative

Additional information: images confirm the presence of a severely stenotic lesion in the proximal left anterior descending (lad) artery.Wiring of the vessel and pre-dilation of the lesion site can be observed, followed by delivery and subsequent deployment of a long stent to the lesion site.Improved bloodflow can be seen through the vessel following stent deployment.Delivery of a post-dilation balloon can be observed.It is unclear if it is the non-mdt balloon used to post-dilate the distal portion of the device or the complaint nc euphora device used to post-dilate the proximal portion of the device.Multiple inflations of the balloon can be observed with no contrast leaks or burst visible.Following inflation the balloon appears to have been withdrawn successfully.Delivery of a second balloon can be observed, followed by an attempt to withdraw the balloon into a guide catheter.Images do not capture the reported burst, deflation difficulties or contrast leak.Multiple attempts to capture the detached balloon in the radial artery can be observed.Only one markerband of the balloon can be observed.Images did not capture the mechanism of detachment.Attempts to withdraw the device into a guide catheter and to capture with a guide extension catheter in the radial artery can be observed, followed by successful withdrawal of the device through the radial artery with a snare and subsequent surgical removal of the device via the patient¿s wrist.Improved bloodflow through the lad can be observed.Images confirm the reported removal difficulties and detachment however the reported deflation difficulties and burst cannot be confirmed.Echo images provided alongside the fluoroscopy procedural images were reviewed by a medtronic medical safety expert.It was stated that the reported deflation difficulties and burst cannot be confirmed.No evidence of severe anatomy (eg.Calcification) was observed.No angiographic evidence of a balloon burst, contrast leak or any vessel complications was observed.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: 15173288
• MDR Text Key: 297313674
• Report Number: 9612164-2022-02951
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2024
• Device Catalogue Number: NCEUP3520X
• Device Lot Number: 223684999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2022
• Date Device Manufactured: 01/25/2022
• 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: 61 YR
• Patient Sex: Male