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
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 3/4/2026: 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.
Additional Manufacturer Narrative
We received the initial complaint on 2026/2/18 as our balloon catheter came apart at distal area of balloon.Then we requested questions regarding more details and got the additional information on 2026/3/4 indicating that the balloon fragment remained in the patient and covered with a wall stent.Then we became alert and determined to report this case.

• 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: 24696380
• Report Number: 3003775186-2026-00098
• Device Sequence Number: 10176356
• 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
• 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): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown