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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 NCSP27512X
Device Problem Deflation Problem (1149)
Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2021
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 nc sprinter rx balloon to treat a mildly tortuous, mildly calcified lesion with 50% stenosis in the mid left anterior descending (lad) artery.   the device was inspected with no issues noted. Negative prep was performed with no issues. The lesion was pre-dilated. The device did pass through a previously-deployed stent. Resistance was encountered when advancing the device. Excessive force was used during delivery. It was reported that deflation difficulties were encountered at the lesion site. It was also reported that even after removing the inflated balloon, it was still not possible to deflate it. The patient is alive with no injury.
 
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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 Key13205526
MDR Text Key283500443
Report Number9612164-2022-00137
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeRP
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,Followup
Report Date 03/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/06/2022
Device Catalogue NumberNCSP27512X
Device Lot Number220912011
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2020
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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