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

Catalog Number EUP2515X

Device Problems Difficult to Remove (1528); Failure to Deflate (4060)

Patient Problems Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 04/07/2021

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 euphora rx ptca balloon catheter to treat a lesion exhibiting 99% stenosis and an acute myocardial infarction located in the right coronary artery (rca).The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.The device was attempted to be used to pre-dilate the lesion, however inflation difficulties occurred.It was stated that dilation was performed at approximately 6atm, but dilation could not be confirmed by fluoroscopy, so deflation was attempted, however it is unknown whether the balloon deflated.The balloon was inflated again and contrast agent was only confirmed in the front portion of the balloon.It was reported that due to poor visibility of the balloon during imaging deflation was attempted but deflation could not be achieved.It was stated that the balloon could not be pulled out, so it was removed for the whole system.It was also reported that ventricular tachycardia (vt) occurred and changed to ventricular fibrillation (vf) due to difficulty in removing the balloon caused by no deflation, however this recovered with direct cardioversion.When the patient recovered, the procedure was started over.One nc euphora ptca balloon catheter was then used to pre-dilate the lesion and two resolute onyx coronary drug eluting stents were implanted.The procedure was completed without issue.

Manufacturer Narrative

Additional information: annex d code added 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: there were no difficulties in removing the protective sheath or packaging stylette.Negative prep was performed on the device prior to use.The device was not kinked and re-straightened during use.On return of the device for analysis, a detachment was found on the distal shaft approx.15.5cm distal to the exchange joint.This occurred after the device was removed from the patient and the device was cut by the account with a scissors.Device evaluation summary: device returned for evaluation.The device returned with a detachment on the distal shaft approx.15.5cm distal to the exchange joint.There appeared to be a clean break across the inner member and inflation lumen at the detachment site.The balloon folds were expanded and contrast was visible within the balloon.Necking and bunching were evident to the proximal balloon bond, with additional bunching visible on the inner member under the balloon folds.It was not possible to perform inflation/deflation testing due to the condition of the returned device.No other issues were noted.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: 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: 11684626
• MDR Text Key: 245983753
• Report Number: 9612164-2021-01515
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: EUP2515X
• Device Lot Number: 221064833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention