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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 SPL20015X
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2021
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 rx ptca balloon catheter to treat a non-tortuous, moderately calcified lesion exhibiting 50% stenosis located in the mid diagonal branch. The device was not inspected. Negative prep was performed with no issues noted. The sprinter legend was being used to pre-dilate the lesion. Resistance was encountered when advancing the device. Excessive force was not used during delivery. It was reported that inflation difficulties initially occurred during balloon inflation. It was also reported that balloon deflation difficulties occurred, the device would not deflate at the lesion site and removal difficulties occurred following balloon inflation. It was stated that the balloon was removed from the patient in a filled state resulting in prolonged operation time. 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 Key11292234
MDR Text Key230698710
Report Number9612164-2021-00549
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSPL20015X
Device Lot Number219454376
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 Received03/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/08/2021 Patient Sequence Number: 1
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