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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. SPRINTER LEGEND CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC, INC. SPRINTER LEGEND CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number SPL25015X
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Pain (1994)
Event Date 08/07/2020
Event Type  malfunction  
Event Description
Elderly female with history of chest pain. Presented with bilateral arm pain as well as jaw pain. Went to cath lab and while testing the device, the metal stylet would not leave that balloon as usual.
 
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Brand NameSPRINTER LEGEND
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC.
4600 nathan lane north
plymouth MN 55442
MDR Report Key10424799
MDR Text Key203477231
Report Number10424799
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPL25015X
Device Lot Number219512061
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/12/2020
Event Location Hospital
Date Report to Manufacturer08/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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