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

Catalog Number EUP1506X

Device Problems Deflation Problem (1149); Difficult to Open or Remove Packaging Material (2922)

Patient Problems Hematoma (1884); Insufficient Information (4580)

Event Date 03/01/2022

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 eupora, solarice, nc euphora, nc solarice and sprinter legend poba balloon catheters and everest inflation device & accessories.Survey results from a cardiovascular surgeon in practice 25 years.In the past two months the physician has used euphora, sprinter legend and everest devices.The physician uses approximately 5 everest, 4 euphora and 3 sprinter legend devices in an average month.During a procedure two nc euphora devices (2.00 x 6 mm and 2.00 x 8 mm), one 1.50 x 6 mm euphora device, two everest devices and one piton y-adaptor were used to treat a totally occluded small vessel.One nc euphora was used for angioplasty alone and the other was used for pre-dilation.The euphora device was used for pre-dilation.Nc euphora: it was reported that deflation difficulties occurred in vivo and intervention was required, sheath stylette removal difficulties occurred during device preparation in vitro.It was reported that the device which was used for angioplasty alone performed unsuccessfully.It was stated that the other device performed successfully.It was also reported that a local hematoma occurred.Euphora: it was reported that deflation difficulties occurred in vivo and intervention was required, sheath stylette removal difficulties occurred during device preparation in vitro.It was also reported that a local hematoma occurred.Everest: it was reported that connection difficulties and physical resistance/sticking occurred in vitro during device preparation of one of the devices.It was also stated that the device was not functioning well.

• 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: 14487384
• MDR Text Key: 292488298
• Report Number: 9612164-2022-01980
• 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: Physician
• 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: EUP1506X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Required Intervention