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

Catalog Number NCEUP3012X

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An attempt was made to use a nc euphora balloon to treat a moderately calcified, non tortuous lesion, with 95% stenosis in the left main (lm) coronary artery.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.The lesion was not 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.The device was not kinked and restraightened during use.It was reported that the balloon catheter was fractured during advancement through the guide catheter.The detached portion of device did not remain in patient.The nc euphora and wire were used to pulled the fractured balloon out.No patient injury was reported.

Manufacturer Narrative

Product analysis: the device returned with a detachment on the hypotube approx.71.2cm distal to the strain relief.A kink was evident to the hypotube.The hypotube material was oval and jagged on both sides of the detachment site.The balloon folds were intact; inflation had not been performed.No damage evident to the balloon material.There was no fracture noted to the balloon.No deformation evident to the distal tip.No other damage evident to the remainder of the device.Product analysis: images show wiring of the left main artery and balloon advancement through the catheter.This balloon does not seem to advance fully to the lesion and appears to be removed along with wires in the final images provided.Reported fracture does not appear to be captured in the images 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.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

Add 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.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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12433171
• MDR Text Key: 270086499
• Report Number: 9612164-2021-03448
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Catalogue Number: NCEUP3012X
• Device Lot Number: 222550755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2021
• 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 Age: 88 YR
• Patient Sex: Male