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

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.

• 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: 10172830
• MDR Text Key: 195723320
• Report Number: 9612164-2020-02261
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• 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 Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/18/2021
• Device Catalogue Number: NCSLC4008X
• Device Lot Number: 218115164
• 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 Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial