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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 SPL12515X
Device Problems Break (1069); Device Damaged Prior to Use (2284); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2020
Event Type  malfunction  
Event Description
Elderly female with history of hypertension and diabetes. While having an elective staged percutaneous coronary intervention to right coronary artery via radial artery access, the sprinter hub was broken in the package. When attempted to use, the inflater would not properly attach, therefore unable to inflate. Another devise was used, no known harm to patient.
 
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Brand NameSPRINTER LEGEND
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key10966915
MDR Text Key220190238
Report Number10966915
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 12/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPL12515X
Device Catalogue NumberSPL12515X
Device Lot Number218648181
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/04/2020
Event Location Hospital
Date Report to Manufacturer12/08/2020
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 Unkown

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