MAUDE Adverse Event Report: MEDTRONIC, INC. EUPHORA; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number EUP2510X

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2019

Event Type  malfunction  

Event Description

Balloon dilation catheter being used in heart to dilate blood vessel.First inflation at 6 atm, no problem, second inflation at 7 atm, no problem, inflation at 8 atm revealed a leak of dye from the balloon indicating a rupture.Balloon deflated, and catheter removed.Second catheter required to complete procedure.Physician inspected the area where the faulty balloon failed and determined no part of the balloon remained in the patient.Physical inspection of balloon did not reveal any missing parts.

• Brand Name: EUPHORA
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 8792991
• MDR Text Key: 151121338
• Report Number: 8792991
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169560000
• UDI-Public: (01)00643169560000(17)210321(10)217347818
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EUP2510X
• Device Lot Number: 217347818
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Weight: 98