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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, Back to Search Results
Model Number NCSP3015X
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Event Date 03/12/2022
Event Type  Injury  
Event Description
An attempt was made to use a nc sprinter balloon catheter. The device was inspected with no issues. It was reported that 26 atm was applied to inflate the balloon. It was reported that the balloon detached from the rod after the balloon burst occurred. A snare was used but failed to snare the balloon. A stent was used to attach the balloon to the blood vessel wall. The patient is alive with no injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameNC SPRINTER 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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13926226
MDR Text Key288024462
Report Number9612164-2022-01190
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
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNCSP3015X
Device Catalogue NumberNCSP3015X
Device Lot Number223306349
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2021
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: 03/28/2022 Patient Sequence Number: 1
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