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

Model Number NCEUP3015X

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 06/20/2023

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device returned for analysis with a cut on the distal shaft with a partial guidewire inserted in the distal tip and with a staple holding the returned distal section into a coil.A non-medtronic stent returned on the balloon.The leur and hypotube did not return for analysis.Bunching was evident to the proximal balloon bond/lumen.Necking was visible on the lumen proximal to the proximal marker band.The balloon folds returned expanded.No deformation was evident to the distal tip.Deflation testing could not be carried out due to the bunching and necking on the inflation lumen.No other deformation 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.

Event Description

An attempt was made to use one nc euphora rx balloon catheter to treat a non-tortuous, non-calcified lesion with 80% stenosis located in the mid left anterior descending (lad) artery during a pci (percutaneous coronary intervention) procedure.The packaging stylette was removed smoothly.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that balloon deflation difficulties and removal difficulties occurred.Following implantation of a non-medtronic stent, the nc euphora was being used to post dilate the distal end of the stent.After the first inflation at 12 atm the nc euphora would not deflate.The balloon was expanded at the distal end of the stent and an attempt was made to deflate and move the proximal end of the stent for expansion, but the balloon could not be deflated at the distal end.An attempt was made to withdraw the balloon into the proximal opening of the stent, however, the balloon was unable to be retracted out of the stent.The balloon and stent were not moved or displaced in the lesion.It was detailed that the contrast agent was attempted to be pumped back with a pressure pump, however, this failed to deflate to the balloon.The pressure pump was replaced and it was repeatedly attempted to pump back the contrast agent, but the balloon failed to deflate and the balloon could not be removed.The balloon could be continued to be pressurized and expanded but could not deflate back when pumping negative pressure.The balloon was inflated to 14 atm in order to attempt to withdraw the balloon.A microcatheter with a guide extension catheter for support, were then used to attempt to puncture the balloon with a non-medtronic guidewire.Various methods were used but the balloon did not deflate and could not be removed.After several hours of trying the patient was sent for cardiac surgery and underwent a thoracotomy to remove the balloon.The balloon and stent were removed.The stent remained intact.During this process the connecting section between the balloon body and the catheter was cut, but the balloon remained inflated after it was removed from the patient.A concentration of 1:3 contrast/saline was used.No further patient injury was reported.

Manufacturer Narrative

Additional information: it was not difficult to remove the protective sheath.The non-medtronic stent was size 3.0x38mm.There were no difficulties noted during inflation of the balloon.Correction: patient age, sex and weight.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: annex d code.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.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: coronary angiography was performed, 40% stenosis was noted in the proximal lad, 70-85% stenosis was noted in the mid lad, 40% stenosis was noted in the proximal diagonal, 80% stenosis in the distal left circumflex (lcx), 50% stenosis in the mid right coronary artery (rca) and 40% stenosis in the distal rca.The decision was made to perform a percutaneous coronary intervention in the lad.Following implantation of a 3.0 x 38mm non-medtronic stent it was expanded to 8atm.A non mdt microcatheter and guide extension catheter were used in the procedure.Repeated attempts were made but the microcatheter could not reach the proximal end of the high pressure balloon.A 1.2 x 6mm and 1.5 x 15mm non mdt balloons were dilated in the obstructed section but were still unable to retract the balloon.The patient was sent for emergency coronary artery bypass graft surgery (cabg).Image analysis: eleven (11) still procedural images were provided from the account.The images show that there are no lesions evident in the rca.There is a lesion in the mid-lad that appears to have been pre-dilated and across which a stent was deployed.No images were provided showing the reported deflation difficulties.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: 17316807
• MDR Text Key: 319028003
• Report Number: 9612164-2023-03165
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NCEUP3015X
• Device Catalogue Number: NCEUP3015X
• Device Lot Number: 224845451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 79 KG