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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO NC SOLARICE RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number NCSLC4008X
Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/14/2020
Event Type  malfunction  
Manufacturer Narrative
Please note that this device (nc solarice) is not marketed in the united states; however, it is similar to the united states marketed product (nc euphora). This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions. If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure an attempt was made to use one nc solarice rx ptca balloon catheter to treat a severely tortuous, severely calcified lesion exhibiting 80% stenosis located in the ostium of the right coronary artery (rca). The device was inspected with no issues noted. Negative prep was performed with no issues noted. The lesion was pre-dilated. The device did not pass through a previously deployed stent. Resistance was encountered when advancing the device. Excessive force was not used during delivery. It was reported that balloon burst/leaked during balloon inflation at 12 atm. It was stated that the event was due to use of the device in difficult lesion morphology/anatomy, i. E. The event was procedural related and not device related. The patient was reported to be alive with no injuries.
 
Manufacturer Narrative
Additional information: the nc solarice was not moved or re-positioned in the lesion while inflated. The event occurred on the first inflation. The same inflation device was successfully used with other devices. Correction: please note that the nc solarice device is not marketed in the united states; however it is considered to be the same as nc euphora with the exception of a different brand name and minor differences in the labelling. For this reason, us fda - mdr reporting for nc solarice devices is completed as if the device was marketed in the united states. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameNC SOLARICE RX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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 
091708734
MDR Report Key10172830
MDR Text Key195723320
Report Number9612164-2020-02261
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K141090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/18/2021
Device Catalogue NumberNCSLC4008X
Device Lot Number218115164
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/19/2019
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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