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

Catalog Number	210-103-5UU
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
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.Background: 1.Other information about the patient that may have influenced the outcome of the event: cabg [coronary artery bypass graft] x 2004, pci [percutaneous coronary intervention] with stent, hyperlipidemia.2.Preexisting characteristics that may have contributed to the event: coronary heart disease; diabetes; hypertension.

• 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 51803-8 ; CH 518038
• MDR Report Key: 21915851
• Report Number: 3003775186-2025-00138
• Device Sequence Number: 8794989
• Product Code: LOX
• UDI-Device Identifier: 06934955942037
• UDI-Public: (01)06934955942037(11)240428(17)260428(10)4231522404
• 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: Other,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 210-103-5UU
• Device Lot Number: 4231522404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2025
• Initial Report FDA Received Date: 04/27/2025
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 87 KG