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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
Catalog Number SPL15010X
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/19/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure an attempt was made to use one sprinter legend ptca balloon catheter to treat a lesion located in the right coronary artery (rca). The device was not inspected. Negative prep was not performed. The lesion was not pre-dilated. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. It was reported that inflation difficulties occurred during balloon inflation. It was also reported that a balloon leak occurred at the catheter during balloon inflation. The patient was reported to be alive with no injury.
 
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Brand NameSPRINTER LEGEND RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
av. paseo del cucapah #10510
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11064191
MDR Text Key223380359
Report Number9612164-2020-05041
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/08/2022
Device Catalogue NumberSPL15010X
Device Lot Number218446608
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 Received12/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/09/2019
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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