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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 SPL12506X
Device Problems Break (1069); Material Rupture (1546)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/04/2017
Event Type  malfunction  
Event Description
During cardiac catheter procedure balloon catheter was inserted through guide catheter and advanced into the lesion, inflated and ruptured and broke off in lesion, multiple attempts made to remove balloon by physicians ultimately resulting in distal embolization of balloon fragment. A decision was made to leave in place by the team.
 
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Brand NameSPRINTER® LEGEND
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC.
3576 unocal place
santa rosa CA 95403
MDR Report Key6577759
MDR Text Key75517193
Report Number6577759
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 User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/09/2017,05/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPL12506X
Device Catalogue NumberSPL12506X
Device Lot Number210065458
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/09/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer05/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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