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

Model Number	EUP2510X
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 8792991
• Report Number: 8792991
• Device Sequence Number: 13911463
• Product Code: LOX
• UDI-Device Identifier: 00643169560000
• UDI-Public: (01)00643169560000(17)210321(10)217347818
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/12/2019
• Report Date (Section F): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EUP2510X
• Device Lot Number: 217347818
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 98
• Date Report Sent to FDA: 07/12/2019