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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC MEXICO SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Stenosis (2263)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the sprinter legend rx ptca balloon catheter survey results from an interventional cardiologist using the devices for the past year. In the past 12 months the physician has used sprinter legend rx 120 times and 1. 25 x 6 mm, 4. 0 x 30 mm and other intermediate sizes were used 2 x coronary vessel dissection (related to the procedure but not directly to sprinter legend rx) and 10 x restenosis of the dilated vessel (within procedure or after procedure and related to the procedure but not directly to sprinter legend rx) were encountered in the using the product over the last 12 months. And were previously reported to medtronic issues regarding radioopacity were noted, it was stated that the physician would like if it was improved.
 
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Brand NameSPRINTER LEGEND RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO
tijuana
Manufacturer (Section G)
MEDTRONIC MEXICO
tijuana
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9277210
MDR Text Key165272538
Report Number9612164-2019-04631
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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