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

Model Number	NCEUP4012X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
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
An attempt was made to use a nc euphora balloon.There was no damage noted to the device packaging.There were no issues noted when removing the device from the protective hoop.The device was inspected with no issues noted.Negative prep was performed with no issues.Resistance was encountered when advancing the device.It was reported that the device failed to cross the lesion and the catheter was deformed with a kink.It was also reported that the physician was able to advance the balloon through a non mdt 6fr extension guide catheter and over a non-mdt wire up to the 2nd marker band, the balloon was then unable to advance any longer and the guide kept backing out of the vessel.All the devices were removed to get a new guide for better engagement and when everything was pulled out, the balloon catheter was noted to be broken in two.All the device parts remained in the guide catheter, therefore no intervention was required to remove the device.The patient is alive with no injury.
Additional Manufacturer Narrative
Additional information: the lesion was moderately to severely calcified, with 85% stenosis, located in the lad.The lesion was not pre-dilated.The device did not pass through a previously-deployed stent.Excessive force was not used during delivery.Excessive force was not used during withdrawal of the device.Resistance was not encountered during withdrawal of the device.The device was not kinked and re-straightened during use.Patient gender is female.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
Device evaluation summary: device returned for evaluation.Kinks were evident on the hypotube proximal and distal to the detachment site.The device returned with a detachment on the hypotube 91.5cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.The device returned with blood visible in the balloon and inflation lumen.Balloon folds appear partially opened.No deformation evident to the distal tip.No other damage evident to the remainder of the device.Correction: device return date (d9) 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12576352
• Report Number: 9612164-2021-03826
• Device Sequence Number: 1113133
• Product Code: LOX
• UDI-Device Identifier: 00643169396227
• UDI-Public: 00643169396227
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/02/2021

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: 07/02/2023
• Device Model Number: NCEUP4012X
• Device Catalogue Number: NCEUP4012X
• Device Lot Number: 222522383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 10/23/2021; 11/18/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 11/16/2021; 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• 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 Sex: Female