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

Model Number	NCEUP5008X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
One nc euphora balloon catheter was attempted to be used.The device was inspected prior to use with no issues noted.It was reported that the device would not deflate at the lesion site.No patient injury reported.
Additional Manufacturer Narrative
Additional information: one nc euphora balloon catheter was attempted to be used to treat a non calcified, non tortuous lesion with 70% stenosis in the left main.It was not difficult to remove the protective sheath.It was not difficult to remove the packaging stylette.Resistance was not noted while advancing the device to the lesion.Excessive was not force used.A concentration of 50/50 contrast/saline was used.Inflation difficulties were not noted.Deflation difficulties were not noted after the first inflation but on subsequent inflations.An inflation of 14 atm for 10 seconds in the lm and 18 atm for 7 seconds in the lad were performed prior to the deflation difficulties.The device was not moved or repositioned while inflated.The balloon deflated enough to remove it but it was still partially inflated and this was not noted until the device was outside of the patient and the catheter.The balloon was removed from the patient as normal without difficulty and with no intervention required.No patient injury reported.Patient medical history and age, weight and gender 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.
Additional Manufacturer Narrative
Additional information: device lot details updated device evaluation summary: the device returned for evaluation.The balloon was deflated on device return.Dried contrast was visible in the balloon and inflation lumen.The distal shaft was kinked.A kink was evident to the proximal balloon bond.Deformation was evident to the distal tip.A support wire/mandrel could not be loaded through the guide wire lumen to support the nc euphora during inflation and deflation testing.The device passed negative prep.The balloon was inflated to 12atms (nominal pressure), then 14atms and then 18atms during analysis with no issues noted.The balloon deflated within 10 seconds on each of the three inflations.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
• Common Device Name: 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: 13838165
• Report Number: 9612164-2022-01057
• Device Sequence Number: 1404460
• Product Code: LOX
• UDI-Device Identifier: 00643169396074
• UDI-Public: 00643169396074
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2023
• Device Model Number: NCEUP5008X
• Device Catalogue Number: NCEUP5008X
• Device Lot Number: 223375605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 04/05/2022; 05/11/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 04/13/2022; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 90 KG