MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV MEDTRONIC EUPHORA SC BALLOON DILATION CATHETER PTCA BALLOON ; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 3.0MM X 20 MM

Device Problems Deflation Problem (1149); Inflation Problem (1310)

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

Event Date 01/22/2020

Event Type  malfunction  

Event Description

Euphora ptca balloon had inflation/deflation problems.Had to be withdrawn from pt partially inflated causing loss of wire and guide catheter position.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC EUPHORA SC BALLOON DILATION CATHETER PTCA BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV
• MDR Report Key: 9636891
• MDR Text Key: 176775841
• Report Number: MW5092551
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2021
• Device Model Number: 3.0MM X 20 MM
• Device Catalogue Number: EUP 3020X
• Device Lot Number: 218537232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 183