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

Catalog Number EUP22510X

Device Problem Use of Device Problem (1670)

Patient Problems Nausea (1970); Vascular Dissection (3160)

Event Date 03/04/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the euphora, solarice, nc euphora, nc solarice and sprinter legend poba balloon catheters, everest inflation device & accessories.Survey results are from a cardiovascular surgeon in practice 13 years.In the past two months, the physician has used euphora rx, sprinter legend and everest devices.The physician uses approximately 4 euphora rx, 2 sprinter legend and 5 everest devices in an average month.During one procedure one euphora rx balloon catheter was used to treat a patient with acute coronary syndrome.The device was being used for angioplasty alone.It was reported that a balloon leak and a detachment occurred in vitro, prior to insertion, when the device was being flushed/prepped.It was also reported that during the procedure a grade a coronary vessel dissection occurred and the patient developed nausea.The dissection was described as being directly related to the euphora rx device, as too high of a pressure was used during dilation.The nausea was reported as being related to the procedure but not directly to the device itself.It was indicated that the device performed successfully in its ability to dilate the stenotic portion of a lesion in the native coronary artery to improve myocardial infusion.No further patient injury reported.

• 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
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14489055
• MDR Text Key: 292522462
• Report Number: 9612164-2022-01987
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EUP22510X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2022
• 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