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

Model Number	NCEUP3520X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
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
One nc euphora balloon catheter was attempted to be used to treat a moderately tortuous, mildly calcified lesion with 80% stenosis in the mid right coronary artery (rca).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 and excessive force was not used.It was reported that the balloon would not deflate at the lesion site.It was stated that the physician attempted to burst the balloon with stiff tipped wire but was unsuccessful so the balloon, guide catheter and guide wire were then removed together.No patient injury reported.
Additional Manufacturer Narrative
Additional information: the was no difficulty removing the protective sheath or packaging stylette.There were no difficulties noted during inflation of the device.There was only one inflation carried out.The device was not moved or repositioned while inflated.The concentration of contrast / saline used was 50:50.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
Product analysis summary: the device returned loaded in a non-medtronic guide catheter and a telescope guide extension catheter (gec).The balloon was partially inflated on device return.The nc euphora was retracted back through the telescope gec and guide catheter.The device was inflated but could not be deflated.On inflation of the balloon, the balloon filled with blood as the inner member became damaged when loading the mandrel.Proximal balloon bond necked.Distal shaft necked also.Deformation evident to the distal tip.No other deformation 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.

• 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
• MDR Report Key: 11999328
• Report Number: 9612164-2021-02315
• Device Sequence Number: 1009533
• Product Code: LOX
• UDI-Device Identifier: 00643169396326
• UDI-Public: 00643169396326
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2021

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: 02/12/2023
• Device Model Number: NCEUP3520X
• Device Catalogue Number: NCEUP3520X
• Device Lot Number: 221679531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 06/25/2021; 09/30/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 07/12/2021; 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 102