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

Catalog Number EUP2025X

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

There was no damage noted to the packaging of the euphora balloon. There were no issues noted when removing the device from the hoop. The device was inspected with no issues. Negative prep was not performed. The lesion was pre-dilated. No abnormalities reported in relation to anatomy. The balloon was inflated to 8 atms with no issues noted. During the second inflation again to 8 atms, contrast leakage was viewed under floro and on removal of the balloon from the patient, there seemed to be a hole in the balloon. No resistance had been encountered when advancing the device. No injury reported.

Manufacturer Narrative

Additional information: the euphora balloon was being used to treat an occluded lesion in the distal lad. A coronary angiography revealed chronic occlusion of the ostial lad. Prior to use of the euphora balloon, two non-mdt stents were successfully deployed. Final flow timi iii was achieved so it was decided to end the procedure. If information is provided in the future, a supplemental report will be issued.

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: 7747090
• MDR Text Key: 116233224
• Report Number: 9612164-2018-01954
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/11/2019
• Device Catalogue Number: EUP2025X
• Device Lot Number: 213827795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial