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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND / MEDTRONIC VASCULAR MEDTRONIC BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS Back to Search Results
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.
 
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Brand NameMEDTRONIC BALLOON CATHETER
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND / MEDTRONIC VASCULAR
MDR Report Key8843283
MDR Text Key152989010
Report NumberMW5088537
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received07/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/21/2021
Device Model NumberEUP3015X
Device Lot Number217371291
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/29/2019 Patient Sequence Number: 1
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