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

Model Number NCEUP3515X

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

An attempt was made to use one nc euphora balloon to treat a moderately tortuous, moderately calcified lesion in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used.The device was not kinked and re-straightened during use.It was reported that device catheter broke during delivery through the vessel.The device did not advance smoothly and there was slight resistance.Once the balloon reached the target lesion the inflation of the balloon was noted to be slow.It appeared that a balloon burst had occurred, however, this was not seen and couldn't be determined.When the device was removed from the guide catheter it was noticed that the shaft was broken.The detached portion of the device does not remain in the patient.The device was removed through normal removal methods, and all pieces of the device were accounted for when removed from the guide catheter.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: some resistance was noted on delivery of the device.Resistance was not noted during removal of the device.Excessive force was not used.The device was not moved or repositioned while inflated.It is unknown if the device was being used to pre-dilate the lesion.It was later reported that when an attempt was made to inflate the balloon, the balloon did not expand and a flush of contrast was noticed as if the balloon had ruptured.It was stated that this was a surprise as the lesion did not appear calcified or fibrotic.It was not believed that the balloon actually inflated as when the flush of contrast was noticed, the attempt to inflate the balloon was stopped and an inflation pressure did not get any higher than 10 atm.The potential burst occurred on the first inflation.On removing the balloon catheter from the guide, when it came out of the hemostatic valve, it was noted that the shaft had fractured into two separate pieces.It appeared to be a clear break and no kink or bend in the catheter shaft was noted prior to insertion.The balloon did not appear winged or if it had been partially inflated and it was stated that it was almost as if the contrast from the inflation device leaked directly from the shaft as opposed to from the balloon.The same inflation device was successfully used with other devices.Product analysis: the device was received for analysis.The device returned with a detachment on the hypotube.Kinks were evident along the length of the hypotube.A kink was evident on the hypotube proximal to the detachment site.The hypotube material was oval and jagged on both sides of the detachment site.No necking was evident to the proximal bond.The device returned with balloon folds intact.The device passed negative prep.Due to the detachment, the distal shaft was removed from the remainder of device to perform inflation testing.The balloon was inflated to a nominal of 12atms and maintained pressure.No burst or inflation issues were evident.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.

• 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: 15877106
• MDR Text Key: 307480275
• Report Number: 9612164-2022-04470
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169396333
• UDI-Public: 00643169396333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141090
• 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: 02/16/2023

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 Model Number: NCEUP3515X
• Device Catalogue Number: NCEUP3515X
• Device Lot Number: 224962520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 01/09/2023; 02/10/2023
• Supplement Dates FDA Received: 02/07/2023; 02/16/2023
• Date Device Manufactured: 08/24/2022
• 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