• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MEXICO NC SOLARICE RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, Back to Search Results
Model Number NCSLC2012X
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2021
Event Type  Injury  
Manufacturer Narrative
Please note that this device (nc solarice) is not marketed in the united states; however, the device is deemed the same as the united states marketed device (nc euphora). If information is provided in the future, a supplemental report will be issued.
 
Event Description
One nc solarice rx balloon catheter was attempted to be used during a procedure to treat a mildy tortuous and mildly calcified lesion. There was no damage noted to the device packaging and no issues noted when removing the device from the hoop. The device was inspected with no issues noted. The lesion was pre-dilated. The device was not kinked and re-straightened during use. The device did not pass through a previously deployed stent. Resistance was encountered when advancing the device but excessive force was not used. It was reported that the device broke/detached at the catheter during advancement of the device through the guide catheter. No patient injury reported.  .
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNC SOLARICE 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 Key12890470
MDR Text Key288055179
Report Number9612164-2021-04620
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K141090
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
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNCSLC2012X
Device Catalogue NumberNCSLC2012X
Device Lot Number222585258
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/14/2021
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: 11/30/2021 Patient Sequence Number: 1
-
-