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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
Catalog Number NCSP37512X
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problems Thrombosis/Thrombus (4440); Insufficient Information (4580)
Event Date 01/10/2022
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
One nc sprinter balloon catheter was attempted to be used during a procedure to treat a mildly tortuous, mildly calcified lesion with 90% stenosis in the mid right coronary artery (rca). The device was being used to post-dilate a deployed stent. The device was not inspected prior to use. Negative prep was performed with no issues noted. The lesion was not pre-dilated. The device did pass through a previously deployed stent. Resistance was not encountered when advancing the device but excessive force was not used. It was reported that a balloon burst occurred at 16 atms. It was stated that the balloon was found to be burst laterally and was laterally cut from the back of the balloon cap, with the balloon remaining in the patient. A thrombus-like reside was noted on the image. The balloon body was removed from the patient using a suction catheter with negative pressure. No further patient injury reported.
 
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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 Key13281392
MDR Text Key283954338
Report Number9612164-2022-00254
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,Followup,Followup
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNCSP37512X
Device Lot Number222944500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/14/2021
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: 01/18/2022 Patient Sequence Number: 1
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