MAUDE Adverse Event Report: MEDTRONIC IRELAND MEDTRONIC SC EUPHORA 2.0MM X 12MM CORONARY BALLOON / REF #: EUP2012X; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number SC EUPHORA

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2021

Event Type  Injury  

Event Description

Patient was undergoing coronary artery intervention and when the balloon was being removed there was some resistance.Upon removal, it was noticed that the balloon catheter tip was missing.Under fluoro it was found that the balloon tip was in the catheter.Guide catheter and all writes removed including balloon tip.No foreign object left in patient.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC SC EUPHORA 2.0MM X 12MM CORONARY BALLOON / REF #: EUP2012X
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 11648229
• MDR Text Key: 245315704
• Report Number: MW5100704
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): Y
• 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: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2022
• Device Model Number: SC EUPHORA
• Device Lot Number: 221379288
• Was Device Available for Evaluation?: No
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 89