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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 NCSP2515X
Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907)
Patient Problems Unspecified Tissue Injury (4559); Insufficient Information (4580)
Event Date 07/19/2021
Event Type  Injury  
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 balloon catheter to treat a moderately tortuous, moderately calcified lesion, with 70% stenosis in the proximal left anterior descending (lad) artery. There was no damage noted to the device packaging. There were no issues noted when removing the device from the protective hoop. The device was inspected with no issues noted. Negative prep was performed with no issues. The lesion was pre-dilated. The device passed through a previously deployed stent. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. The device was not moved or repositioned while inflated. No difficulties were noted during inflation of the device. It was reported that balloon deflation difficulties were encountered, the device would not deflate at the lesion site. The device was punctured and completely explanted. Interventional surgery was changed to bypass, and the patient was transferred out of icu. The balloon was removed during the bypass surgery. The deflation difficulties did not occur after the first inflation. The patient is alive, with 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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12300691
MDR Text Key265799965
Report Number9612164-2021-03068
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 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNCSP2515X
Device Catalogue NumberNCSP2515X
Device Lot Number221952491
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2021
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: 08/10/2021 Patient Sequence Number: 1
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