MAUDE Adverse Event Report: MEDTRONIC IRELAND / MEDTRONIC VASCULAR MEDTRONIC BALLOON CATHETER; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS

Model Number EUP3015X

Device Problem Material Rupture (1546)

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

Event Date 06/10/2019

Event Type  Injury  

Event Description

Pci of calcified left main, 3 different balloons ruptured.The pre balloon, the stent balloon, and the post nc balloon before we used a cutting balloon.

• Brand Name: MEDTRONIC BALLOON CATHETER
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND / MEDTRONIC VASCULAR
• MDR Report Key: 8843283
• MDR Text Key: 152989010
• Report Number: MW5088537
• 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: 07/23/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2021
• Device Model Number: EUP3015X
• Device Lot Number: 217371291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR