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

Catalog Number NCSLC3520X

Device Problem Leak/Splash (1354)

Patient Problems Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

Please note that this device, nc solarice is not marketed in the united states; however, it is considered the same as the united states marketed product nc euphora.Evaluation summary: the balloon returned partially inflated with residue present inside the balloon.Deformation was evident to the distal tip.Negative prep failed to detect the presence of a leak.Upon pressurisation of the device, a leak was observed on the balloon proximal working length.Upon visual inspection, a short radial tear was observed on the balloon proximal working length.The balloon material was jagged and uneven at the tear site.Lead in scratch was visible proximal to the tear site.Image review: the images capture the lesion site in the proximal rca as reported by the account.Calcification is visible in the proximal section of the vessel.A previously deployed unidentified stent is visible in the proximal rca.Balloon inflation within the previously deployed stent that is being treated for in-stent re-stenosis can be seen.Subsequent images capture the burst of the nc solarice balloon.Contrast is seen leaking from the vessel proximal to the balloon.A spiral dissection is evident in the vessel post balloon burst.An unidentified stent is then deployed at the site.The dissection shows residual contrast in the vessel.

Event Description

The physician intended to use a nc solarice balloon catheter to treat a lesion located in a non-tortuous proximal right coronary artery (rca), which was reported to have 75% stenosis, no other abnormalities were reported in relation to anatomy.No damage was noted to packaging and no issues were noted when removing the devices from the tray/hoop.The devices were inspected with no issues identified.Negative prep was also performed with no issues.The lesion was pre-dilated.Resistance was encountered when advancing the device but no excessive force was used during delivery.It was reported that during the procedure, the nc solarice balloon was inflated to 16atm but the lesion could not be opened.18 atm pressure was then applied.The balloon burst during the inflation.This caused a small amount of damage to the vessel, which was described as a dissection.The balloon was not moved or repositioned in the lesion prior to the burst.The physician used a stent to treat the damaged vessel.The physician does not believe that the event was due to use of the device in difficult lesion morphology/anatomy.

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: 6649959
• MDR Text Key: 77863622
• Report Number: 9612164-2017-00780
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2018
• Device Catalogue Number: NCSLC3520X
• Device Lot Number: 211370797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2016
• 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): Required Intervention
• Patient Age: 64 YR