MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. SAPPHIRE NC PLUS CORONARY DILATATION CATHETER

Catalog Number 235-183-2U

Device Problem Break (1069)

Patient Problem Stenosis (2263)

Event Type  Injury  

Event Description

Information from (b)(6) 2020: the sapphire nc plus balloon broke during removal.The fragment was removed with a snare.Information from (b)(6) 2020: "a lhc was performed from right common femoral access.After the heart cath images were obtained of the left lower extremity.It was determined that a focal stenosis was present at the origin of the at.At this point a 6f x 45cm destination sheath was placed up and over into the left sfa.A 0.014 grandslam wire was used to cross the at lesion.The stenosis was first pre-dilated with a 3mm mustang balloon, the lesion was noted to be unchanged.At this point the 3.5x18 sapphire nc balloon was advanced across the lesion and inflated to 12atms for 20 seconds.Then upon removal the physician felt no resistance but the shaft of the balloon broke leaving 2/3 of the balloon catheter inside the patient's leg.The sheath was then upsized to an 8f sheath.At this point multiple attempts were made to snare the catheter without success.Then left common femoral access was obtained and a snare was advanced.The physician was then able to snare the balloon catheter with a 35mm loop snare.At this point the balloon catheter, the snare system, and the sheath was removed all at the same time.Manual pressure was then held until hemostasis was obtained.The procedure was then continued.The at was wired again with a grandslam wire and a 4x40 nanocross was used to successful balloon the lesion.All equipment was removed and manual pressure was held on the right common femoral artery until hemostasis was obtained." patient has hx of htn and dmii.Additional information from 2/8/2020: no kinks or bends were noted during the advancement of the balloon catheter.No kinks or bends were noted during the removal of the balloon catheter.The catheter broke at the proximal shaft about 30-40cm down the catheter.The lesion was located at the origin of the at and 70% stenosed.The vessel was not tortuous, with minimal to no calcium noted on the angio.

• Brand Name: SAPPHIRE NC PLUS CORONARY DILATATION CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no.1st jinkui road; futian free trade zone; shenzhen guangdong, shenzhen guangdong CN 5 1803; CH CN 51803
• MDR Report Key: 9909229
• MDR Text Key: 196250599
• Report Number: 3014148220-2020-00597
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 235-183-2U
• Device Lot Number: 3402251901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/05/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention