MAUDE Adverse Event Report: ORBUSHNEICH MEDICAL (SHENZHEN) CO., LTD. SAPPHIRE NC PLUS CORONARY DILATATION CATHETER; PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Model Number	492502612
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All known information has been reported and no additional information is anticipated.No follow up report is necessary at this time.If additional information is received, a supplemental report will be sent.Csi id: (b)(4).
Event or Problem Description
The sapphire balloon was used for treatment.A perforation was observed.A covered stent placement was performed to treat the perforation and complete the procedure.The patient was stable.

• Brand Name: SAPPHIRE NC PLUS CORONARY DILATATION CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
• Manufacturer (Section D): ORBUSHNEICH MEDICAL (SHENZHEN) CO., LTD.; no. 1 jinkui road; futian free trade zone; shenzen, 51803 8; CH 518038
• MDR Report Key: 18164651
• Report Number: 3004742232-2023-00284
• Device Sequence Number: 12423674
• Product Code: LOX
• UDI-Device Identifier: 06934955905360
• UDI-Public: (01)06934955905360(11)230607(17)250607(10)4942932305
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2023
• Report Date (Section F): 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2025
• Device Model Number: 492502612
• Device Catalogue Number: 7-10095-35
• Device Lot Number: 4942932305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/23/2023
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/17/2023