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

Model Number NCEUP3012X

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems Myocardial Infarction (1969); Obstruction/Occlusion (2422)

Event Date 06/13/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure an attempt was made to use one nc euphora rx ptca balloon catheter to treat a non tortuous and non calcified lesion in the distal rca with less than 20% stenosis.The device was inspected with no issues.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.Excessive force was not used during delivery.It was reported that removal difficulties were experienced following the second balloon inflation at 18atm.The balloon was ruptured from the shaft, with flow obstruction as a result and shutdown of the rca with transmural ischemia.It was reported that the patient had possible myocardial infraction.The patient is reported to be alive with injury.

Manufacturer Narrative

Additional information: the balloon being used to post-dilate the deployed stent and ruptured on it's second inflation attempt.The balloon was not moved or repositioned while inflated.It was later confirmed that the patient suffered an mi post procedure.The patient is reported to be alive with injury and was discharged home.Relevant history updated (b7) five still images were provided for review.The images provided appear to show a damaged and deflated balloon, with contrast/blood present on/in 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.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

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: a non-medtronic guide wire was received with the device.There was a complete radial burst on the balloon mid-working length.The balloon material at the burst site was jagged and uneven.The inner member had detached.The inner member at the detachment site was stretched and uneven.The detached distal section, distal section of the balloon and distal tip were loaded on the non-medtronic guide wire.The distal tip was bunched.It was not possible to remove the detached section of the device from the guidewire due to the bunched tip.There was no other damage 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

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: images show pre-dilation of the right coronary artery before deployment of stents to the lesion.Multiple post-dilations of the stents are observed.The nc euphora device burst is not captured in the images provided but we can confirm that the distal inflation lumen/proximal balloon bond has expanded and inflated and this is what most likely burst on the second inflation, and this is confirmed by the characteristics of the returned device.Images also confirm the bunching of the catheter marker bands suggesting that removal difficulties were experienced, and confirming some of the characteristics on the returned device.Final angiographic images show that the rca appears to be successfully treated.Clarification of analysis, inflation lumen/proximal balloon bond burst as opposed to the balloon as previously reported.There was a complete radial burst of the distal inflation lumen/proximal balloon bond area of the catheter, the balloon had not burst.The distal outer shaft material at the burst site was jagged and uneven.The inner member had stretched and detached.The inner member at the detachment site was stretched and uneven.The detached distal section, distal section of the balloon and distal tip were still loaded on the non-medtronic guide wire.The distal tip was severely bunched and the inner member was separated from the tip under the distal balloon cone at the tip seal bond.It was not possible to remove the detached section of the device from the guidewire due to the bunched tip.There was no other damage evident to the remainder of the device.It was not possible to perform any functional testing due to the severely damaged nature of the device that was returned for analysis.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
• MDR Report Key: 12065306
• MDR Text Key: 258300412
• Report Number: 9612164-2021-02481
• 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,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2023
• Device Model Number: NCEUP3012X
• Device Catalogue Number: NCEUP3012X
• Device Lot Number: 221816206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Date Manufacturer Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR