MAUDE Adverse Event Report: MEDTRONIC IRELAND MEDTRONIC EUPHORA BALLOON RX 3.00MM X 15MM; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number EUP3015X

Device Problems Material Fragmentation (1261); Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/08/2020

Event Type  Injury  

Event Description

During an angiogram in the left leg, a 3.0 mm (euphora) coronary balloon was used to attempt to dilate the lesion.The balloon ruptured and the tip of the catheter fragmented and remained stuck in the calcified lesion.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC EUPHORA BALLOON RX 3.00MM X 15MM
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 10378937
• MDR Text Key: 202364628
• Report Number: MW5095944
• 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: 08/05/2020

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
• Device Operator: Health Professional
• Device Model Number: EUP3015X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2020
• 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): Hospitalization
• Patient Weight: 60