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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. 1.25MM X 15MM SPRINTER LEGEND, OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS

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MEDTRONIC, INC. 1.25MM X 15MM SPRINTER LEGEND, OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS Back to Search Results
Model Number SPL12515WL
Device Problems Material Fragmentation (1261); Difficult to Remove (1528); Material Rupture (1546)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/08/2018
Event Type  Injury  
Event Description
Pt arrived to cardiac cath lab for angiography/poss pci. Intervention of the highly calcific mid lad was performed. After rupture, a 1. 25 x 12 mm medtronic sprinter legend balloon was unable to be removed. After some time, the balloon was removed leaving behind some balloon material thus occluding the lad. The balloon fragment was unable to be removed. The pt was placed on an iabp and transferred to a neighboring facility for emergent cabg. A 1. 25mm x 15mm sprinter legend, otw balloon ref# (b)(4). Dates of use: (b)(6) 2018. Diagnosis or reason for use: ptca.
 
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Brand Name1.25MM X 15MM SPRINTER LEGEND, OTW
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key7818788
MDR Text Key118472500
Report NumberMW5079410
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 Other Health Care Professional
Type of Report Initial
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSPL12515WL
Device Catalogue NumberSPL12515WL
Device Lot Number214951797
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2018
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/24/2018 Patient Sequence Number: 1
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