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

Catalog Number EUP2012X

Device Problems Burst Container or Vessel (1074); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem Vascular Dissection (3160)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a euhpora rx balloon catheter was attempted to be used to pre-dilate a mildly tortuous, severely calcified lesion with chronic total occlusion in the mid rca.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.Negative prep was performed with no issues.The lesion was pre-dilated using a 1.25x12 mm sprinter legend balloon.The euphora device did not pass through a previously deployed stent.Resistance was encountered when advancing the device, excessive force was not used.It is reported that the euphora device was advanced and when inflated above rated burst pressure (16 atms) the balloon burst.The euphora balloon was used for several inflations in the lesion area.It burst on the last inflation.A sudden drop in pressure noted on the inflation device.A dissection was noted at the balloon burst site.A 2.5x12 mm euphora device was then delivered and inflated for 1 minute.There was an angiographical improvement and it was confirmed that there was no perforation.No further patient complications reported for this event.

Manufacturer Narrative

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

• Brand Name: 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
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7731101
• MDR Text Key: 115368788
• Report Number: 9612164-2018-01888
• Device Sequence Number: 0
• Product Code: LOX
• Reporter Country Code: US
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2019
• Device Catalogue Number: EUP2012X
• Device Lot Number: 215320118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 04/23/2018
• 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