MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD SAPPHIRE II PRO BALLOON DILATATION CATHETER; Catheters, transluminal coronary angioplasty, percutaneous

Catalog Number	225-123-5UU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a sapphire balloon was being used to treat mildly calcified, mildly tortuous, 70% stenosed left main artery (lm).After inflation within an existing 2.5mm 2024 unspecified stent, contrast stain was observed.It was reported that there were patient complications (perforation/vessel damage) treated lesion information: mildly calcified, mildly tortuous, 70% stenosed, lm no returned device and no case image/cd were provided for analysis.

• Brand Name: SAPPHIRE II PRO BALLOON DILATATION CATHETER
• Common Device Name: Catheters, transluminal coronary angioplasty, percutaneous
• Manufacturer (Section D): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer (Section G): ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803 8; CH 518038
• Manufacturer Contact: yuki li ; no.1st jinkui road; futian free trade zone; shenzhen, guangdong 51803-9 ; CH 518039
• MDR Report Key: 25145529
• Report Number: 3003775186-2026-00233
• Device Sequence Number: 18823901
• Product Code: LOX
• UDI-Device Identifier: 06934955942242
• UDI-Public: (01)06934955942242(11)251031(17)271031(10)4298942510
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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 Catalogue Number: 225-123-5UU
• Device Lot Number: 4298942510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown