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

Catalog Number	220-203-5UU
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information indicated the balloon fragment remained in the patient and covered with a wall stent was received on (b)(6) 2026.
Event or Problem Description
It was reported that a sapphire ii balloon came apart at distal area of balloon.First additional information was received on 03/04/2026: 1.Provide a detailed summary of event from beginning to end, including troubleshooting and resolution.- waiting on email from hospital.2.Anatomical information? (vessel / location / tortuosity / calcification / stenosis % / etc.) - unknown.3.Please provide patient demographics (gender, age, weight, race, ethnicity) and comorbidities.If unavailable, please provide reason why (e.G.Hospital privacy policy) - i thought i chose the hospital private policy.4.Did the balloon become fully detached or was it damaged intact? - it looks like it's detached.5.How was the balloon fragment(s) removed from the patient? - he remains with a wall stent covering.6.If fragment(s) remain in vivo - does the physician have any concerns about potential long-term risk outcomes? - the hospital should be sending information.7.What is the status of the patient? - unknown.Second additional information was received on 3/13/2026: 1.Provide a detailed summary of event from beginning to end, including troubleshooting and resolution.- it seems they were using this in a mine coronary case and will not answer any other information.2.At which stage of the procedure did the product separate? - unknown.3.Anatomical information? (vessel / location / tortuosity / calcification / stenosis % / etc.) - unknown, but not heart.4.If fragment(s) remain in vivo - does the physician have any concerns about potential long-term risk outcomes? - unknown they covered with a (wall stent).5.What is the status of the patient? - unknown.6.Was any resistance or abnormality detected prior to the separation? - unknown.7.Had the balloon been inflated prior to the separation, and if so, what was the inflation pressure? - unknown.

• 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
• MDR Report Key: 24696400
• Report Number: 3014148220-2026-00098
• Device Sequence Number: 10557072
• Product Code: LOX
• UDI-Device Identifier: 06934955942198
• UDI-Public: (01)06934955942198(11)250910(17)270910(10)4283422508
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 220-203-5UU
• Device Lot Number: 4283422508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Distributor Facility Aware Date: 02/18/2026
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2026
• 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