MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. SAPPHIRE NC 24 CORONARY DILATATION CATHETER; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	492501512
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160); Embolism/Embolus (4438)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Na.
Event or Problem Description
During procedure to treat 90% stenosed heavily calcified posterior lateral artery, the sapphire balloon was inflated twice at 18 atmospheres.The balloon did not inflate completely.The balloon was deflated and during removal, the distal part of the balloon came off and the fragment was left inside the artery.There was non-flow limiting dissection in the mid right coronary artery (rca) and an abbott drug eluting stent was used to treat the dissection.In the opinion of the physician, the cause of dissection was the lesion and not sapphire balloon.The patient was stable.
Additional Manufacturer Narrative
H10: manufacturer report number updated fields: f6, f7, f10 (code 4438 no longer applies, code 2687 added), f11, f13, h10.
Event or Problem Description
During procedure to treat 90% stenosed heavily calcified posterior lateral artery, the sapphire balloon was inflated twice at 18 atmospheres.The balloon did not inflate completely.The balloon was deflated and during removal, the distal part of the balloon came off and the fragment was left inside the artery.There was non-flow limiting dissection in the mid rca and an abbott drug eluting stent was used to treat the dissection.In the opinion of the physician, the cause of dissection was the lesion and not sapphire balloon.The patient was stable.

• Brand Name: SAPPHIRE NC 24 CORONARY DILATATION CATHETER
• 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: 22108284
• Report Number: 3004742232-2025-00156
• Device Sequence Number: 20633539
• Product Code: LOX
• UDI-Device Identifier: 06934955905339
• UDI-Public: (01)06934955905339(17)270211(10)4909472501
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025
• Report Date (Section F): 06/03/2025

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 Model Number: 492501512
• Device Catalogue Number: 492501512
• Device Lot Number: 4909472501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/30/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/03/2025
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/03/2025