MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV EUPHORA BALLOON 1.5 X 20"; CATHETER, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number EUP1520X

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504); Obstruction of Flow (2423); Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 10/21/2022

Event Type  malfunction  

Event Description

Pt in procedure, left heart catheterization.Pt was found to have a blockage in the right coronary artery that need to be opened.The balloon that was used was not able to cross the lesion, however was found to have a hole in it.Before crossing the lesion we pull negative on the balloon, when this was done in this case there was blood return (which is not supposed to happen).Because the balloon was not able to cross the lesion it was taken out of the body.At this time, the balloon was attempted to be inflated and did not.Fda safety report id # (b)(4).

• Brand Name: EUPHORA BALLOON 1.5 X 20"
• Type of Device: CATHETER, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV
• MDR Report Key: 15680500
• MDR Text Key: 302612068
• Report Number: MW5112900
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EUP1520X
• Device Lot Number: 223906413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White