MAUDE Adverse Event Report: ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD SAPPHIRE NC 24 CORONARY DILATATION CATHETER; Catheters, transluminal coronary angioplasty, percutaneous

Catalog Number	492501512
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During procedure to treat heavily calcified posterior lateral artery, the sapphire balloon was inflated twice.The balloon did not inflate completely.The balloon was deflate and during removal, the distal part of the balloon came off and the fragment was left inside the artery.There was dissection in the rca and an abbott stent was used.It is unknown if dissection was caused due to the sapphire balloon or the procedure.The patient was stable.Additional information was received on 2025/5/21: 1.The sapphire nc 24 balloon was the first balloon used to inflate.2.The specific vessel location(s) that sapphire balloon inflated was the posterior lateral artery.3.The sapphire balloon was inflated to 18 atmospheres.4.The vessel was 90% stenosed.The diameter of the inflated vessel was unavailable.5.It is unknown if any resistance or abnormality felt during the balloon removal.6.The dissection occur in the mid of rca.7.In the opinion of the physician, the cause of dissection was the lesion and not the sapphire balloon.8.The dissection was non-flow limiting.

• 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.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: 22111538
• Report Number: 3003775186-2025-00166
• Device Sequence Number: 4251364
• Product Code: LOX
• UDI-Device Identifier: 06934955905339
• UDI-Public: (01)06934955905339(11)250211(17)270211(10)4909472501
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K211807
• 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): 05/30/2025

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: 492501512
• Device Lot Number: 4909472501
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/29/2025
• 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: Required Intervention
• Patient Sex: Unknown