MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. SAPPHIRE II PRO; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	210-103-5UU
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: procedure is estimated as (b)(6) 2025.H10: manufacturer report number.
Event or Problem Description
It was reported that the intended procedures were left heart catheterization, bypass graft angiography and plain old balloon angioplasty (poba) of the right posterior descending artery (rpda).The 1.0 x10 mm sapphire balloon came off of the delivery catheter and was permanently lodged in rpda.

• Brand Name: SAPPHIRE II PRO
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.; no. 1 jinkui road; futian free trade zone; shang hai shi, shanghai 51803 8; CH 518038
• MDR Report Key: 21960481
• Report Number: 3004742232-2025-00127
• Device Sequence Number: 9197558
• Product Code: LOX
• UDI-Device Identifier: 06934955942037
• UDI-Public: (01)06934955942037(17)260428(10)4231522404
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2025
• Report Date (Section F): 05/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2026
• Device Model Number: 210-103-5UU
• Device Catalogue Number: 210-103-5UU
• Device Lot Number: 4231522404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/10/2025
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White
• Date Report Sent to FDA: 05/05/2025