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

Catalog Number NCEUP2515X

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

One nc euphora balloon catheter was attempted to be used to treat a moderately tortuous, mildly calcified lesion in the mid lad.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did not 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 was slow to deflate at the lesion site.It was stated that the physician noticed another spot appear and quickly removed the whole balloon.It was stated that the physician noted extra balloon material on the proximal part of the balloon.It was also stated that the extra spot was not noticed on the first inflation, but on the second and third inflation the extra or additional balloon area was noted to be getting bigger.No patient injury reported.

Manufacturer Narrative

Additional information: there were no issues when removing the balloon protector and stylette from over the balloon.No issues were experienced when back-loading the guidewire into the device.The device was not moved or re-positioned while inflated.14 atm of inflation pressure was applied to the device in order to achieve the first inflation.The initial inflation time was slower than expected.14 atm of inflation pressure was applied to the device in order to achieve the second and third balloon inflations.Deflation difficulties were experienced for all attempts including the first attempt at deflation.It was stated that the ¿spot¿ appeared on the second inflation.Difficulty was experienced when removing the balloon from the patient.It was later stated that the balloon was slowly removed as usual.Intervention was not required when removing the device from the patient.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

Product analysis summary: the balloon folds were expanded.The inner member underneath the proximal balloon bond was damaged.The proximal balloon bond and a section of the distal shaft appeared to have inflated.It was not possible to inflate the balloon in order to perform inflation/deflation testing due to the condition of the proximal balloon bond and distal shaft.The inner lumen could not be verified with a 0.015inch mandrel most likely due to hardened blood in the guidewire lumen.No other damage was 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.

Manufacturer Narrative

Additional information: procedural image received shows an inflated balloon in an unidentified lesion, with the shaft proximal to the balloon also appearing expanded and filled with contrast.The expansion of the shaft appears to have occurred during the 2nd inflation.This suggests that the shaft may have been weakened and then on pressurisation of the catheter the weakened shaft expanded.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, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10642008
• MDR Text Key: 218992686
• Report Number: 9612164-2020-03805
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/04/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2022
• Device Catalogue Number: NCEUP2515X
• Device Lot Number: 220086890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/08/2020; 12/01/2020; 01/27/2021
• Supplement Dates FDA Received: 10/29/2020; 12/11/2020; 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR