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

Model Number NCEUP3508X

Device Problem Burst Container or Vessel (1074)

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

Event Date 11/05/2022

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 nc euphora coronary balloon catheter to treat a moderately tortuous, moderately calcified lesion with 85% stenosis, located in the proximal left anterior descending (lad) artery.The device was not inspected.Negative prep was not performed.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during the delivery.It was reported that the balloon burst during balloon inflation.The balloon burst at 15 atms on the first inflation while post dilating.The patient is alive with no injury.

Manufacturer Narrative

Additional information: the device was being used to post-dilate a deployed stent.The device was neither moved nor repositioned while inflated.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: updated lot # product analysis the device was received for analysis.A kink was evident on the hypotube.Blood was visible along the length of the inflation lumen and the balloon.The balloon folds were still folded; no inflation expansion of the balloon folds appeared to have taken place.Damage was evident to the balloon material of all three balloon folds.Deformation was evident to the distal section of the balloon with tears and punctures present.A tear was evident on balloon fold one, scratches were evident proximal to the tear, and a d-shaped puncture was evident proximal to the scratches and tear.The balloon folds were opened for further analysis and it was noted that the puncture had preforated through both walls of the fold, through balloon fold two, and through the inner member.A tear was evident on the balloon fold two.A puncture was evident on balloon fold three.The fold was opened and it was noted that the puncture had preforated through through both walls of the fold and through balloon fold one.The distal tip was bunched.The device was placed in a water bath in an attempt to disperse the blood, however the blood failed to disperse.Negative purge was pulled on the catheter but no evidence of bubbles or a leak was evident, however this was most likely due to the blood blocking the inflation lumen and balloon.Inflation of the balloon was not possible due to the presence of contrast/blood residue within the inflation lumen.Therefore burst/leak testing could not be completed through pressurisation of the catheter.However, due to the damage to the balloon material it can be confirmed that the contrast/saline inflation media would have escaped from the balloon when pressurised during use and therefore this confirms the presence of a leak/burst site on the damaged balloon material thought which contrast would have escaped.This would have appeared like a balloon burst during use.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.

• 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: 15851949
• MDR Text Key: 307304439
• Report Number: 9612164-2022-04384
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2024
• Device Model Number: NCEUP3508X
• Device Catalogue Number: NCEUP3508X
• Device Lot Number: 224256997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 11/29/2022; 02/27/2023
• Supplement Dates FDA Received: 12/19/2022; 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2022
• 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 Sex: Male