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

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.

• Brand Name: NC SOLARICE RX
• Type of Device: CATHETERS, 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 Key: 6525235
• MDR Text Key: 73781548
• Report Number: 9612164-2017-00519
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2018
• Device Catalogue Number: NCSLC5015X
• Device Lot Number: 211299875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Date Device Manufactured: 05/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening