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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 NCSLC5015X
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problems Intimal Dissection (1333); Cardiac Tamponade (2226)
Event Date 12/21/2016
Event Type  Injury  
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the physician was attempting to use a nc solarice balloon during a procedure to treat a rca lesion. It was reported that no issues were noted to device packaging or issues removing the device from the hoop / tray. The device was inspected with no issues noted. Following dilatation of the vessel, a wrong size balloon was used, which was also on the table. Instead of the 3mm, the 5mm was used. This caused a ruptured vessel with coronary intrapericardial bleeding. Patient went into shock due to tamponade and had to undergo intubation and cpr. A 3. 0 mm balloon was inflated proximally into the rca and a pericardial punction was performed. Because of asystole, an external pacemaker was placed in the rv. Over 100ml blood was evacuated from the pericardial cavity. By means of echo it was confirmed that the pericardial diffusion became less. After resuscitation the patient regained rhythm and output. With difficulty, using a liner, 2 covered stents placed. A little extr avasation remained. A balloon was used for post dilation and no extravasation remained. The rca remained open with timi iii flow. Drain in the pericardium and the external pacemaker was left in situ. The vein was closed with tr band. Protamine was given. After a long stay in intensive care and at the hospital, the patient was released from hospital. It was reported that there is no complaint being made about the quality of the product. Please note that this device (b)(4) is not marketed in the united states; however, the device is deemed the same as the united states marketed device (b)(4).
 
Manufacturer Narrative
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 Key6525235
MDR Text Key73781548
Report Number9612164-2017-00519
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeNL
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 03/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/23/2018
Device Catalogue NumberNCSLC5015X
Device Lot Number211299875
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 Received03/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/23/2016
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: 04/27/2017 Patient Sequence Number: 1
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