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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,

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MEDTRONIC MEXICO SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, Back to Search Results
Catalog Number SPL25020X
Device Problem Deflation Problem (1149)
Patient Problems Ischemia (1942); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
An attempt was made to use a sprinter legend rx balloon to treat a severely calcified and tortuous lesion with 75% diffuse stenosis in the right coronary artery. There were no difficulties noted to remove the protective sheath and packaging stylette. The device was inspected with no issues noted. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. The device was not moved or repositioned while inflated. Normal saline 0. 9% was used with contrast agent. It was reported that the balloon failed to deflate, deflation difficulties were encountered after subsequent inflations of the ballo on. No difficulties were noted during inflation and one inflation at 16 atm was performed prior to the deflation difficulties. The balloon catheter was withdrawn smoothly after repeated operations. All surgical instruments were replaced. It was also reported that the balloon lumen was blocked and the gas could not be released leading to a transient ischemia that was reversed following the balloon removal. No intervention was required. The patient is healthy without discomfort. No patient injury was reported.
 
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Brand NameSPRINTER LEGEND RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
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 Key12671208
MDR Text Key277697266
Report Number9612164-2021-04040
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 Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSPL25020X
Device Lot Number217151258
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/19/2019
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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